A. KATEGORI DAN SUB KATEGORI ALAT KESEHATAN

1. PERALATAN KIMIA KLINIK DAN TOKSIKOLOGI KLINIK

1). a. Sistem Tes Kimia Klinik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 862.1030 Alanine amino transferase (ALT/SGPT) test system I
2. § 862.1040 Aldolase test system I
3. § 862.1060 Delta-aminolevulinic acid test system I
4. § 862.1065 Ammonia test system I
5. § 862.1075 Androstenedione test system I
6. § 862.1080 Androsterone test system I
7. § 862.1095 Ascorbic acid test system I
8. § 862.1115 Urinary bilirubin and its conjugates (nonquantitative) test system I
9. § 862.1130 Blood volume test system I
10. § 862.1135 C-peptides of proinsulin test system I
11. § 862.1165 Catecholamines (total) test system. I
12. § 862.1175 Cholesterol (total) test system I
13. § 862.1180 Chymotrypsin test system I
14. § 862.1185 Compound S (11-deoxycortisol) test system I
15. § 862.1190 Copper test system I
16. § 862.1195 Corticoids test system I
17. § 862.1200 Corticosterone test system I
18. § 862.1210 Creatine test system I
19. § 862.1240 Cystine test system I
20. § 862.1245 Dehydroepiandrosterone (free and sulfate) test system I
21. § 862.1250 Desoxycorticosterone test system I
22. § 862.1255 2,3-Diphosphoglyceric acid test system I
23. § 862.1260 Estradiol test system I
24. § 862.1265 Estriol test system I
25. § 862.1270 Estrogens (total, in pregnancy) test system. I
26. § 862.1275 Estrogens (total, nonpregnancy) test system I
27. § 862.1280 Estrone test system I
28. § 862.1285 Etiocholanolone test system. I
29. § 862.1290 Fatty acids test system I
30. § 862.1300 Follicle-stimulating hormone test system. I
31. § 862.1305 Formiminoglutamic acid (FIGLU) test system I
32. § 862.1310 Galactose test system I
33. § 862.1320 Gastric acidity test system I
34. § 862.1325 Gastrin test system I
35. § 862.1330 Globulin test system I
36. § 862.1335 Glucagon test system. I
37. § 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system I
38. § 862.1365 Glutathione test system I
39. § 862.1370 Human growth hormone test system I
40. § 862.1375 Histidine test system I
41. § 862.1380 Hydroxybutyric dehydrogenase test system. I
42. § 862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test system I
43. § 862.1390 5-Hydroxyindole acetic acid/serotonin test system I
44. § 862.1395 17-Hydroxyprogesterone test system. I
45. § 862.1400 Hydroxyproline test system I
46. § 862.1405 Immunoreactive insulin test system. I
47. § 862.1410 Iron (non-heme) test system I
48. § 862.1415 Iron-binding capacity test system I
49. § 862.1420 Isocitric dehydrogenase test system I
50. § 862.1430 17-Ketosteroids test system I
51. § 862.1435 Ketones (nonquantitative) test system I
52. § 862.1450 Lactic acid test system I
53. § 862.1460 Leucine aminopeptidase test system. I
54. § 862.1465 Lipase test system I
55. § 862.1470 Lipid (total) test system I
56. § 862.1475 Lipoprotein test system I
57. § 862.1485 Luteinizing hormone test system I
58. § 862.1490 Lysozyme (muramidase) test system I
59. § 862.1495 Magnesium test system I
60. § 862.1500 Malic dehydrogenase test system I
61. § 862.1505 Mucopolysaccharides (nonquantitative) test system I
62. § 862.1510 Nitrite (nonquantitative) test system I
63. § 862.1520 5′-Nucleotidase test system I
64. § 862.1530 Plasma oncometry test system I
65. § 862.1535 Ornithine carbamyl transferase test system I
66. § 862.1540 Osmolality test system I
67. § 862.1542 Oxalate test system I
68. § 862.1550 Urinary pH (nonquantitative) test system I
69. § 862.1560 Urinary phenylketones (nonquantitative) test system. I
70. § 862.1565 6-Phosphogluconate dehydrogenase test system. I
71. § 862.1570 Phosphohexose isomerase test system. I
72. § 862.1575 Phospholipid test system. I
73. § 862.1580 Phosphorus (inorganic) test system I
74. § 862.1590 Porphobilinogen test system I
75. § 862.1595 Porphyrins test system I
76. § 862.1605 Pregnanediol test system I
77. § 862.1610 Pregnanetriol test system. I
78. § 862.1615 Pregnenolone test system I
79. § 862.1620 Progesterone test system I
80. § 862.1625 Prolactin (lactogen) test system I
81. § 862.1630 Protein (fractionation) test system I
82. § 862.1640 Protein-bound iodine test system I
83. § 862.1645 Urinary protein or albumin (nonquantitative) test system I
84. § 862.1650 Pyruvate kinase test system I
85. § 862.1655 Pyruvic acid test system I
86. § 862.1660 Quality control material (assayed and unassayed). I
87. § 862.1670 Sorbitol dehydrogenase test system I
88. § 862.1680 Testosterone test system I
89. § 862.1705 Triglyceride test system I
90. § 862.1720 Triose phosphate isomerase test system I
91. § 862.1725 Trypsin test system I
92. § 862.1730 Free tyrosine test system. I
93. § 862.1775 Uric acid test system. I
94. § 862.1780 Urinary calculi (stones) test system I
95. § 862.1785 Urinary urobilinogen (nonquantitative) test system I
96. § 862.1790 Uroporphyrin test system I
97. § 862.1795 Vanilmandelic acid test system I
98. § 862.1805 Vitamin A test system I
99. § 862.1815 Vitamin E test system I
100. § 862.1820 Xylose test system. I
101. § 862.1020 Acid phosphatase (total or prostatic) test system II
102. § 862.1025 Adrenocorticotropic hormone (ACTH) test system II
103. § 862.1035 Albumin test system. II
104. § 862.1045 Aldosterone test system II
105. § 862.1050 Alkaline phosphatase or isoenzymes test system II
106. § 862.1055 Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry II
107. § 862.1070 Amylase test system II
108. § 862.1085 Angiotensin I and renin test system II
109. § 862.1090 Angiotensin converting enzyme (A.C.E.) test system II
110. § 862.1100 Aspartate amino transferase (AST/SGOT) test system II
111. § 862.1110 Bilirubin (total or direct) test system II
112. § 862.1113 Bilirubin (total and unbound) in the neonate test system II
113. § 862.1117 B-type natriuretic peptide test system II
114. § 862.1118 Biotinidase test system II
115. § 862.1120 Blood gases (PO2) and blood pH test system II
116. § 862.1140 Calcitonin test system II
117. § 862.1145 Calcium test system II
118. § 862.1150 Calibrator. II
119. § 862.1155 Human chorionic gonadotropin (HCG) test system II
120. § 862.1160 Bicarbonate/carbon dioxide test system II
121. § 862.1170 Chloride test system II
122. § 862.1177 Cholylglycine test system II
123. § 862.1187 Conjugated sulfolithocholic acid (SLCG) test system II
124. § 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system II
125. § 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system. II
126. § 862.1225 Creatinine test system II
127. § 862.1230 Cyclic AMP test system II
128. § 862.1235 Cyclosporine test system II
129. § 862.1295 Folic acid test system II
130. § 862.1315 Galactose-1-phosphate uridyl transferase test system II
131. § 862.1340 Urinary glucose (nonquantitative) test system II
132. § 862.1345 Glucose test system II
133. § 862.1377 Urinary homocystine (nonquantitative) test system II
134. § 862.1440 Lactate dehydrogenase test system II
135. § 862.1445 Lactate dehydrogenase isoenzymes test system II
136. § 862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test system II
137. § 862.1509 Methylmalonic acid (nonquantitative) test system II
138. § 862.1515 Nitrogen (amino-nitrogen) test system II
139. § 862.1545 Parathyroid hormone test system II
140. § 862.1555 Phenylalanine test system II
141. § 862.1585 Human placental lactogen test system II
142. § 862.1600 Potassium test system II
143. § 862.1635 Total protein test system II
144. § 862.1665 Sodium test system II
145. § 862.1675 Blood specimen collection device II
146. § 862.1678 Tacrolimus test system II
147. § 862.1685 Thyroxine-binding globulin test system II
148. § 862.1690 Thyroid stimulating hormone test system II
149. § 862.1695 Free thyroxine test system II
150. § 862.1700 Total thyroxine test system. II
151. § 862.1710 Total triiodothyronine test system. II
152. § 862.1715 Triiodothyronine uptake test system II
153. § 862.1770 Urea nitrogen test system II
154. § 862.1810 Vitamin B12 test system. II
155. § 862.1825 Vitamin D test system II

1). b. Peralatan Laboratorium klinik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use I
2. § 862.2100 Calculator/data processing module for clinical use I
3. § 862.2140 Centrifugal chemistry analyzer for clinical use I
4. § 862.2150 Continuous flow sequential multiple chemistry analyzer for clinical use I
5. § 862.2160 Discrete photometric chemistry analyzer for clinical use I
6. § 862.2170 Micro chemistry analyzer for clinical use I
7. § 862.2230 Chromatographic separation material for clinical use I
8. § 862.2250 Gas liquid chromatography system for clinical use. I
9. § 862.2260 High pressure liquid chromatography system for clinical use I
10. § 862.2270 Thin-layer chromatography system for clinical use. I
11. § 862.2300 Colorimeter, photometer, or spectrophotometer for clinical use I
12. § 862.2310 Clinical sample concentrator. I
13. § 862.2320 Beta or gamma counter for clinical use. I
14. § 862.2400 Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use. I
15. § 862.2485 Electrophoresis apparatus for clinical use I
16. § 862.2500 Enzyme analyzer for clinical use. I
17. § 862.2540 Flame emission photometer for clinical use I
18. § 862.2560 Fluorometer for clinical use I
19. § 862.2680 Microtitrator for clinical use I
20. § 862.2700 Nephelometer for clinical use. I
21. § 862.2720 Plasma oncometer for clinical use I
22. § 862.2730 Osmometer for clinical use I
23. § 862.2750 Pipetting and diluting system for clinical use. I
24. § 862.2800 Refractometer for clinical use I
25. § 862.2850 Atomic absorption spectrophotometer for clinical use I
26. § 862.2860 Mass spectrometer for clinical use. I
27. § 862.2900 Automated urinalysis system I
28. § 862.2920 Plasma viscometer for clinical use. I
29. § 862.2570 Instrumentation for clinical multiplex test systems II

1). c. Sistem Tes Toksikologi klinik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 862.3050 Breath-alcohol test system I
2. § 862.3110 Antimony test system I
3. § 862.3120 Arsenic test system I
4. § 862.3220 Carbon monoxide test system I
5. § 862.3240 Cholinesterase test system I
6. § 862.3280 Clinical toxicology control material. I
7. § 862.3600 Mercury test system I
8. § 862.3750 Quinine test system I
9. § 862.3850 Sulfonamide test system I
10. § 862.3030 Acetaminophen test system II
11. § 862.3035 Amikacin test system II
12. § 862.3040 Alcohol test system II
13. § 862.3080 Breath nitric oxide test system II
14. § 862.3100 Amphetamine test system II
15. § 862.3150 Barbiturate test system II
16. § 862.3170 Benzodiazepine test system II
17. § 862.3200 Clinical toxicology calibrator II
18. § 862.3250 Cocaine and cocaine metabolite test system II
19. § 862.3270 Codeine test system II
20. § 862.3300 Digitoxin test system II
21. § 862.3320 Digoxin test system II
22. § 862.3350 Diphenylhydantoin test system II
23. § 862.3360 Drug metabolizing enzyme genotyping system II
24. § 862.3380 Ethosuximide test system II
25. § 862.3450 Gentamicin test system II
26. § 862.3520 Kanamycin test system II
27. § 862.3550 Lead test system II
28. § 862.3555 Lidocaine test system II
29. § 862.3560 Lithium test system II
30. § 862.3580 Lysergic acid diethylamide (LSD) test system. II
31. § 862.3610 Methamphetamine test system II
32. § 862.3620 Methadone test system II
33. § 862.3630 Methaqualone test system II
34. § 862.3640 Morphine test system II
35. § 862.3645 Neuroleptic drugs radioreceptor assay test system. II
36. § 862.3650 Opiate test system II
37. § 862.3660 Phenobarbital test system II
38. § 862.3670 Phenothiazine test system II
39. § 862.3680 Primidone test system II
40. § 862.3700 Propoxyphene test system II
41. § 862.3830 Salicylate test system II
42. § 862.3840 Sirolimus test system II
43. § 862.3870 Cannabinoid test system II
44. § 862.3880 Theophylline test system II
45. § 862.3900 Tobramycin test system II
46. § 862.3910 Tricyclic antidepressant drugs test system II
47. § 862.3950 Vancomycin test system II

2. PERALATAN HEMATOLOGI DAN PATOLOGI

2). a. Pewarna Biological

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 864.1850 Dye and chemical solution stains I
2. § 864.1860 Immunohistochemistry reagents and kits. II

2). b. Produk Kultur Sel dan Jaringan

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 864.2220 Synthetic cell and tissue culture media and components I
2. § 864.2240 Cell and tissue culture supplies and equipment I
3. § 864.2260 Chromosome culture kit. I
4. § 864.2280 Cultured animal and human cells I
5. § 864.2360 Mycoplasma detection media and components I
6. § 864.2800 Animal and human sera. I
7. § 864.2875 Balanced salt solutions or formulations I

2). c. Peralatan dan Asesori Patologi

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 864.3010 Tissue processing equipment I
2. § 864.3250 Specimen transport and storage container I
3. § 864.3260 OTC test sample collection systems for drugs of abuse testing I
4. § 864.3300 Cytocentrifuge I
5. § 864.3400 Device for sealing microsections I
6. § 864.3600 Microscopes and accessories I
7. § 864.3800 Automated slide stainer I
8. § 864.3875 Automated tissue processor I

2). d. Pereaksi Penyedia Specimen

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 864.4010 General purpose reagent I
2. § 864.4400 Enzyme preparations I
3. § 864.4020 Analyte specific reagents II

2). e. Peralatan Hematologi Otomatis dan Semi Otomatis

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 864.5240 Automated blood cell diluting apparatus I
2. § 864.5350 Microsedimentation centrifuge I
3. § 864.5800 Automated sedimentation rate device I
4. § 864.5850 Automated slide spinner I
5. § 864.5200 Automated cell counter II
6. § 864.5220 Automated differential cell counter II
7. § 864.5260 Automated cell-locating device II
8. § 864.5300 Red cell indices device II
9. § 864.5400 Coagulation instrument. II
10. § 864.5425 Multipurpose system for in vitro coagulation studies. II
11. § 864.5600 Automated hematocrit instrument. II
12. § 864.5620 Automated hemoglobin system II
13. § 864.5680 Automated heparin analyzer II
14. § 864.5700 Automated platelet aggregation system II
15. § 864.5950 Blood volume measuring device II

2). f.  Peralatan Hematologi Manual

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 864.6150 Capillary blood collection tube I
2. § 864.6160 Manual blood cell counting device I
3. § 864.6600 Osmotic fragility test I
4. § 864.6700 Erythrocyte sedimentation rate test. I
5. § 864.6100 Bleeding time device II
6. § 864.6400 Hematocrit measuring device II
7. § 864.6550 Occult blood test II
8. § 864.6650 Platelet adhesion test. II
9. § 864.6675 Platelet aggregometer II

2). g. Paket dan Kit hematologi

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 864.7040 Adenosine triphosphate release assay I
2. § 864.7660 Leukocyte alkaline phosphatase test I
3. § 864.7675 Leukocyte peroxidase test I
4. § 864.7900 Thromboplastin generation test. I
5. § 864.7060 Antithrombin III assay II
6. § 864.7100 Red blood cell enzyme assay II
7. § 864.7140 Activated whole blood clotting time tests II
8. § 864.7250 Erythropoietin assay. II
9. § 864.7275 Euglobulin lysis time tests II
10. § 864.7280 Factor V Leiden DNA mutation detection systems. II
11. § 864.7290 Factor deficiency test. II
12. § 864.7300 Fibrin monomer paracoagulation test II
13. § 864.7320 Fibrinogen/fibrin degradation products assay II
14. § 864.7340 Fibrinogen determination system II
15. § 864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay. II
16. § 864.7375 Glutathione reductase assay. II
17. § 864.7400 Hemoglobin A2 assay. II
18. § 864.7415 Abnormal hemoglobin assay II
19. § 864.7425 Carboxyhemoglobin assay. II
20. § 864.7440 Electrophoretic hemoglobin analysis system II
21. § 864.7455 Fetal hemoglobin assay II
22. § 864.7470 Glycosylated hemoglobin assay II
23. § 864.7490 Sulfhemoglobin assay. II
24. § 864.7500 Whole blood hemoglobin assays II
25. § 864.7525 Heparin assay. II
26. § 864.7695 Platelet factor 4 radioimmunoassay II
27. § 864.7720 Prothrombin consumption test II
28. § 864.7735 Prothrombin-proconvertin test and thrombotest II
29. § 864.7750 Prothrombin time test II
30. § 864.7825 Sickle cell test. II
31. § 864.7875 Thrombin time test II
32. § 864.7925 Partial thromboplastin time tests II

2). h. Pereaksi Hematologi

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 864.8200 Blood cell diluent. I
2. § 864.8500 Lymphocyte separation medium I
3. § 864.8540 Red cell lysing reagent I
4. § 864.8950 Russell viper venom reagent. I
5. § 864.8100 Bothrops atrox reagent II
6. § 864.8150 Calibrator for cell indices II
7. § 864.8165 Calibrator for hemoglobin or hematocrit measurement II
8. § 864.8175 Calibrator for platelet counting II
9. § 864.8185 Calibrator for red cell and white cell counting II
10. § 864.8625 Hematology quality control mixture II

2). i. Produk yang digunakan dalam pembuatan sediaan darah dan sediaan berasal dan darah

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 864.9050 Blood bank supplies I
2. § 864.9125 Vacuum-assisted blood collection system I
3. § 864.9185 Blood grouping view box I
4. § 864.9195 Blood mixing devices and blood weighing devices I
5. § 864.9225 Cell-freezing apparatus and reagents for in vitro diagnostic use I
6. § 864.9275 Blood bank centrifuge for in vitro diagnostic use. I
7. § 864.9320 Copper sulfate solution for specific gravity determinations. I
8. § 864.9750 Heat-sealing device I
9. § 864.9100 Empty container for the collection and processing of blood and blood components II
10. § 864.9145 Processing system for frozen blood II
11. § 864.9160 Blood group substances of nonhuman origin for in vitro diagnostic use. II
12. § 864.9175 Automated blood grouping and antibody test system II
13. § 864.9205 Blood and plasma warming device II
14. § 864.9285 Automated cell-washing centrifuge for immuno-hematology II
15. § 864.9300 Automated Coombs test systems II
16. § 864.9400 Stabilized enzyme solution II
17. § 864.9550 Lectins and protectins II
18. § 864.9575 Environmental chamber for storage of platelet concentrate II
19. § 864.9600 Potentiating media for in vitro diagnostic use. II
20. § 864.9650 Quality control kit for blood banking reagents II
21. § 864.9700 Blood storage refrigerator and blood storage freezer II
22. § 864.9875 Transfer set. II
23. § 864.9245 Automated blood cell separator II

3 . PERALATAN IMUNOLOGI DAN MIKROBIOLOGI

3). a. Peralatan Diagnostika

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 866.1620 Antimicrobial susceptibility test disc II
2. § 866.1640 Antimicrobial susceptibility test powder II
3. § 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system II
4. § 866.1700 Culture medium for antimicrobial susceptibility tests II

3). b. Peralatan Mikrobiologi

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 866.2050 Staphylococcal typing bacteriophage I
2. § 866.2120 Anaerobic chamber I
3. § 866.2160 Coagulase plasma. I
4. § 866.2170 Automated colony counter I
5. § 866.2180 Manual colony counter I
6. § 866.2300 Multipurpose culture medium I
7. § 866.2320 Differential culture medium I
8. § 866.2330 Enriched culture medium I
9. § 866.2350 Microbiological assay culture medium I
10. § 866.2360 Selective culture medium I
11. § 866.2390 Transport culture medium I
12. § 866.2440 Automated medium dispensing and stacking device I
13. § 866.2450 Supplement for culture media I
14. § 866.2480 Quality control kit for culture media I
15. § 866.2500 Microtiter diluting and dispensing device I
16. § 866.2540 Microbiological incubator I
17. § 866.2560 Microbial growth monitor I
18. § 866.2580 Gas-generating device I
19. § 866.2600 Wood’s fluorescent lamp I
20. § 866.2660 Microorganism differentiation and identification device I
21. § 866.2850 Automated zone reader I
22. § 866.2900 Microbiological specimen collection and transport device I
23. § 866.2410 Culture medium for pathogenic Neisseria spp II
24. § 866.2420 Oxidase screening test for gonorrhea II

3). c. Pereaksi Serologi

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 866.3010 Acinetobacter calcoaceticus serological reagents I
2. § 866.3020 Adenovirus serological reagents I
3. § 866.3035 Arizona spp. serological reagents I
4. § 866.3040 Aspergillus spp. serological reagents I
5. § 866.3065 Bordetella spp. serological reagents I
6. § 866.3110 Campylobacter fetus serological reagents I
7. § 866.3120 Chlamydia serological reagents I
8. § 866.3125 Citrobacter spp. serological reagents I
9. § 866.3140 Corynebacterium spp. serological reagents I
10. § 866.3145 Coxsackievirus serological reagents I
11. § 866.3200 Echinococcus spp. serological reagents I
12. § 866.3205 Echovirus serological reagents I
13. § 866.3235 Epstein-Barr virus serological reagents I
14. § 866.3240 Equine encephalomyelitis virus serological reagents I
15. § 866.3250 Erysipelothrix rhusiopathiae serological reagents I
16. § 866.3255 Escherichia coli serological reagents I
17. § 866.3270 Flavobacterium spp. serological reagents I
18. § 866.3330 Influenza virus serological reagents I
19. § 866.3340 Klebsiella spp. serological reagents. I
20. § 866.3355 Listeria spp. serological reagents. I
21. § 866.3360 Lymphocytic choriomeningitis virus serological reagents. I
22. § 866.3370 Mycobacterium tuberculosis immunofluorescent reagents I
23. § 866.3375 Mycoplasma spp. serological reagents I
24. § 866.3380 Mumps virus serological reagents I
25. § 866.3400 Parainfluenza virus serological reagents I
26. § 866.3405 Poliovirus serological reagents I
27. § 866.3410 Proteus spp. (Weil-Felix) serological reagents I
28. § 866.3470 Reovirus serological reagents I
29. § 866.3480 Respiratory syncytial virus serological reagents I
30. § 866.3490 Rhinovirus serological reagents I
31. § 866.3500 Rickettsia serological reagents I
32. § 866.3520 Rubeola (measles) virus serological reagents I
33. § 866.3600 Schistosoma spp. serological reagents I
34. § 866.3630 Serratia spp. serological reagents I
35. § 866.3680 Sporothrix schenckii serological reagents I
36. § 866.3700 Staphylococcus aureus serological reagents I
37. § 866.3720 Streptococcus spp. exoenzyme reagents I
38. § 866.3740 Streptococcus spp. serological reagents I
39. § 866.3850 Trichinella spiralis serological reagents I
40. § 866.3870 Trypanosoma spp. serological reagents I
41. § 866.3050 Beta-glucan serological assays II
42. § 866.3060 Blastomyces dermatitidis serological reagents II
43. § 866.3085 Brucella spp. serological reagents II
44. § 866.3135 Coccidioides immitis serological reagents II
45. § 866.3165 Cryptococcus neoformans serological reagents II
46. § 866.3175 Cytomegalovirus serological reagents II
47. § 866.3210 Endotoxin assay II
48. § 866.3220 Entamoeba histolytica serological reagents II
49. § 866.3280 Francisella tularensis serological reagents II
50. § 866.3290 Gonococcal antibody test (GAT) II
51. § 866.3300 Haemophilus spp. serological reagents II
52. § 866.3305 Herpes simplex virus serological reagents II
53. § 866.3310 Hepatitis A virus (HAV) serological assays II
54. § 866.3320 Histoplasma capsulatum serological reagents. II
55. § 866.3332 Reagents for detection of specific novel influenza A viruses II
56. § 866.3350 Leptospira spp. serological reagents II
57. § 866.3390 Neisseria spp. direct serological test reagents II
58. § 866.3402 Plasmodium Species Antigen Detection Assays II
59. § 866.3415 Pseudomonas spp. serological reagents II
60. § 866.3460 Rabiesvirus immunofluorescent reagents II
61. § 866.3510 Rubella virus serological reagents II
62. § 866.3550 Salmonella spp. serological reagents II
63. § 866.3660 Shigella spp. serological reagents II
64. § 866.3780 Toxoplasma gondii serological reagents II
65. § 866.3820 Treponema pallidum nontreponemal test reagents II
66. § 866.3830 Treponema pallidum treponemal test reagents II
67. § 866.3900 Varicella-zoster virus serological reagents II
68. § 866.3930 Vibrio cholerae serological reagents II
69. § 866.3940 West Nile virus serological reagents II
70. § 866.3950 In vitro human immunodeficiency virus (HIV) drug resistance genotype assay. II

3). d. Perlengkapan dan Pereaksi Laboratorium Imunologi

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 866.4100 Complement reagent I
2. § 866.4500 Immunoelectrophoresis equipment. I
3. § 866.4520 Immunofluorometer equipment I
4. § 866.4540 Immunonephelometer equipment I
5. § 866.4600 Ouchterlony agar plate I
6. § 866.4800 Radial immunodiffusion plate I
7. § 866.4830 Rocket immunoelectrophoresis equipment. I
8. § 866.4900 Support gel I
9. § 866.4070 RNA Preanalytical Systems II
10. § 866.4700 Automated fluorescence in situ hybridization (FISH) enumeration systems II

3). e. Sistem Tes Imunologikal

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 866.5060 Prealbumin immunological test system I
2. § 866.5065 Human allotypic marker immunological test system I
3. § 866.5160 Beta-globulin immunological test system. I
4. § 866.5170 Breast milk immunological test system I
5. § 866.5200 Carbonic anhydrase B and C immunological test system I
6. § 866.5220 Cohn fraction II immunological test system I
7. § 866.5230 Colostrum immunological test system I
8. § 866.5330 Factor XIII, A, S, immunological test system I
9. § 866.5360 Cohn fraction IV immunological test system I
10. § 866.5370 Cohn fraction V immunological test system I
11. § 866.5400 Alpha-globulin immunological test system I
12. § 866.5420 Alpha-1-glycoproteins immunological test system I
13. § 866.5425 Alpha-2-glycoproteins immunological test system I
14. § 866.5430 Beta-2-glycoprotein I immunological test system I
15. § 866.5440 Beta-2-glycoprotein III immunological test system I
16. § 866.5520 Immunoglobulin G (Fab fragment specific) immunological test system. I
17. § 866.5530 Immunoglobulin G (Fc fragment specific) immunological test system I
18. § 866.5540 Immunoglobulin G (Fd fragment specific) immunological test system I
19. § 866.5560 Lactic dehydrogenase immunological test system I
20. § 866.5570 Lactoferrin immunological test system I
21. § 866.5590 Lipoprotein X immunological test system I
22. § 866.5700 Whole human plasma or serum immunological test system I
23. § 866.5715 Plasminogen immunological test system I
24. § 866.5735 Prothrombin immunological test system I
25. § 866.5765 Retinol-binding protein immunological test system I
26. § 866.5800 Seminal fluid (sperm) immunological test system I
27. § 866.5860 Total spinal fluid immunological test system I
28. § 866.5890 Inter-alpha trypsin inhibitor immunological test system I
29. § 866.5180 Fecal calprotectin immunological test system II
30. § 866.5040 Albumin immunological test system II
31. § 866.5080 Alpha-1-antichymotrypsin immunological test system II
32. § 866.5090 Antimitochondrial antibody immunological test system II
33. § 866.5110 Antiparietal antibody immunological test system II
34. § 866.5120 Antismooth muscle antibody immunological test system II
35. § 866.5130 Alpha-1-antitrypsin immunological test system II
36. § 866.5150 Bence-Jones proteins immunological test system II
37. § 866.5210 Ceruloplasmin immunological test system II
38. § 866.5240 Complement components immunological test system II
39. § 866.5250 Complement C1 inhibitor (inactivator) immunological test system II
40. § 866.5260 Complement C3b inactivator immunological test system. II
41. § 866.5270 C-reactive protein immunological test system II
42. § 866.5320 Properdin factor B immunological test system II
43. § 866.5340 Ferritin immunological test system II
44. § 866.5350 Fibrinopeptide A immunological test system II
45. § 866.5380 Free secretory component immunological test system II
46. § 866.5460 Haptoglobin immunological test system II
47. § 866.5470 Hemoglobin immunological test system II
48. § 866.5490 Hemopexin immunological test system II
49. § 866.5500 Hypersensitivity pneumonitis immunological test system II
50. § 866.5510 Immunoglobulins A, G, M, D, and E immunological test system II
51. § 866.5550 Immunoglobulin (light chain specific) immunological test system II
52. § 866.5580 Alpha-1-lipoprotein immunological test system II
53. § 866.5600 Low-density lipoprotein immunological test system II
54. § 866.5620 Alpha-2-macroglobulin immunological test system II
55. § 866.5630 Beta-2-microglobulin immunological test system II
56. § 866.5640 Infectious mononucleosis immunological test system II
57. § 866.5680 Myoglobin immunological test system II
58. § 866.5750 Radioallergosorbent (RAST) immunological test system II
59. § 866.5775 Rheumatoid factor immunological test system II
60. § 866.5785 Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems II
61. § 866.5820 Systemic lupus erythematosus immunological test system II
62. § 866.5870 Thyroid autoantibody immunological test system II
63. § 866.5880 Transferrin immunological test system II
64. § 866.5900 Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system. II
65. § 866.5910 Quality control material for cystic fibrosis nucleic acid assays. II
66. § 866.5100 Antinuclear antibody immunological test system III
67. § 866.5660 Multiple autoantibodies immunological test system III

3). f. Sistem Tes Imunologikal Antigen Tumor

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 866.6010 Tumor-associated antigen immunological test system II
2. § 866.6020 Immunomagnetic circulating cancer cell selection and enumeration system II
3. § 866.6030 AFP-L3% immunological test system II
4. § 866.6040 Gene expression profiling test system for breast cancer prognosis. II

4. PERALATAN ANASTESI

4). a. Peralatan Anestesi Diagnostik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 868.1030 Manual algesimeter I
2. § 868.1100 Arterial blood sampling kit I
3. § 868.1575 Gas collection vessel. I
4. § 868.1870 Gas volume calibrator. I
5. § 868.1910 Esophageal stethoscope. I
6. § 868.1930 Stethoscope head. I
7. § 868.1965 Switching valve (ploss). I
8. § 868.1975 Water vapor analyzer. I
9. § 868.1040 Powered algesimeter. II
10. § 868.1075 Argon gas analyzer. II
11. § 868.1150 Indwelling blood carbon dioxide partial pressure (PCO2) analyzer. II
12. § 868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer. II
13. § 868.1200 Indwelling blood oxygen partial pressure (PO2) analyzer. II
14. § 868.1400 Carbon dioxide gas analyzer. II
15. § 868.1430 Carbon monoxide gas analyzer. II
16. § 868.1500 Enflurane gas analyzer. II
17. § 868.1620 Halothane gas analyzer. II
18. § 868.1640 Helium gas analyzer. II
19. § 868.1670 Neon gas analyzer. II
20. § 868.1690 Nitrogen gas analyzer. II
21. § 868.1700 Nitrous oxide gas analyzer. II
22. § 868.1720 Oxygen gas analyzer. II
23. § 868.1730 Oxygen uptake computer. II
24. § 868.1750 Pressure plethysmograph. II
25. § 868.1760 Volume plethysmograph. II
26. § 868.1780 Inspiratory airway pressure meter. II
27. § 868.1800 Rhinoanemometer. II
28. § 868.1840 Diagnostic spirometer. II
29. § 868.1850 Monitoring spirometer. II
30. § 868.1860 Peak-flow meter for spirometry. II
31. § 868.1880 Pulmonary-function data calculator. II
32. § 868.1890 Predictive pulmonary-function value calculator. II
33. § 868.1900 Diagnostic pulmonary-function interpretation calculator. II
34. § 868.1920 Esophageal stethoscope with electrical conductors. II
35. § 868.1120 Indwelling blood oxyhemoglobin concentration analyzer III

4). b. Peralatan Anestesi Pemantauan

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 868.2300 Bourdon gauge flowmeter. I
2. § 868.2320 Uncompensated thorpe tube flowmeter. I
3. § 868.2340 Compensated thorpe tube flowmeter. I
4. § 868.2350 Gas calibration flowmeter. I
5. § 868.2610 Gas pressure gauge. I
6. § 868.2620 Gas pressure calibrator. I
7. § 868.2700 Pressure regulator. I
8. § 868.2875 Differential pressure transducer. I
9. § 868.2885 Gas flow transducer. I
10. § 868.2900 Gas pressure transducer. I
11. § 868.2025 Ultrasonic air embolism monitor. II
12. § 868.2375 Breathing frequency monitor. II
13. § 868.2377 Apnea monitor. II
14. § 868.2380 Nitric oxide analyzer. II
15. § 868.2385 Nitrogen dioxide analyzer. II
16. § 868.2480 Cutaneous carbon dioxide (PcCO2) monitor. II
17. § 868.2500 Cutaneous oxygen (PcO2) monitor. II
18. § 868.2550 Pneumotachometer. II
19. § 868.2600 Airway pressure monitor. II
20. § 868.2775 Electrical peripheral nerve stimulator. II
21. § 868.2450 Lung water monitor. III

4). c. Peralatan Anestesi Terapetik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 868.5100 Nasopharyngeal airway. I
2. § 868.5110 Oropharyngeal airway. I
3. § 868.5220 Blow bottle. I
4. § 868.5240 Anesthesia breathing circuit. I
5. § 868.5280 Breathing tube support. I
6. § 868.5300 Carbon dioxide absorbent. I
7. § 868.5310 Carbon dioxide absorber. I
8. § 868.5320 Reservoir bag. I
9. § 868.5340 Nasal oxygen cannula. I
10. § 868.5350 Nasal oxygen catheter. I
11. § 868.5365 Posture chair for cardiac or pulmonary treatment. I
12. § 868.5375 Heat and moisture condenser (artificial nose). I
13. § 868.5420 Ether hook. I
14. § 868.5460 Therapeutic humidifier for home use. I
15. § 868.5530 Flexible laryngoscope. I
16. § 868.5540 Rigid laryngoscope. I
17. § 868.5550 Anesthetic gas mask. I
18. § 868.5560 Gas mask head strap. I
19. § 868.5570 Nonrebreathing mask I
20. § 868.5580 Oxygen mask. I
21. § 868.5590 Scavenging mask. I
22. § 868.5600 Venturi mask. I
23. § 868.5620 Breathing mouthpiece. I
24. § 868.5640 Medicinal nonventilatory nebulizer (atomizer). I
25. § 868.5675 Rebreathing device. I
26. § 868.5700 Nonpowered oxygen tent. I
27. § 868.5760 Cuff spreader. I
28. § 868.5770 Tracheal tube fixation device. I
29. § 868.5780 Tube introduction forceps. I
30. § 868.5790 Tracheal tube stylet. I
31. § 868.5795 Tracheal tube cleaning brush. I
32. § 868.5810 Airway connector. I
33. § 868.5820 Dental protector. I
34. § 868.5860 Pressure tubing and accessories. I
35. § 868.5975 Ventilator tubing. I
36. § 868.5995 Tee drain (water trap) I
37. § 868.5090 Emergency airway needle. II
38. § 868.5115 Device to relieve acute upper airway obstruction. II
39. § 868.5120 Anesthesia conduction catheter. II
40. § 868.5130 Anesthesia conduction filter. II
41. § 868.5140 Anesthesia conduction kit. II
42. § 868.5150 Anesthesia conduction needle. II
43. § 868.5160 Gas machine for anesthesia or analgesia. II
44. §868.5165 Nitric oxide administration apparatus. II
45. §868.5170 Laryngotracheal topical anesthesia applicator. II
46. § 868.5180 Rocking bed. II
47. § 868.5250 Breathing circuit circulator. II
48. § 868.5260 Breathing circuit bacterial filter. II
49. § 868.5270 Breathing system heater. II
50. § 868.5330 Breathing gas mixer. II
51. § 868.5430 Gas-scavenging apparatus. II
52. § 868.5440 Portable oxygen generator. II
53. § 868.5450 Respiratory gas humidifier. II
54. § 868.5470 Hyperbaric chamber. II
55. § 868.5630 Nebulizer. II
56. § 868.5650 Esophageal obturator. II
57. § 868.5655 Portable liquid oxygen unit. II
58. § 868.5665 Powered percussor. II
59. § 868.5690 Incentive spirometer. II
60. § 868.5710 Electrically powered oxygen tent. II
61. § 868.5720 Bronchial tube. II
62. § 868.5730 Tracheal tube. II
63. § 868.5740 Tracheal/bronchial differential ventilation tube. II
64. § 868.5750 Inflatable tracheal tube cuff. II
65. § 868.5800 Tracheostomy tube and tube cuff. II
66. § 868.5830 Autotransfusion apparatus. II
67. § 868.5870 Nonrebreathing valve. II
68. § 868.5880 Anesthetic vaporizer. II
69. § 868.5895 Continuous ventilator. II
70. § 868.5905 Noncontinuous ventilator (IPPB). II
71. § 868.5915 Manual emergency ventilator. II
72. § 868.5925 Powered emergency ventilator. II
73. § 868.5935 External negative pressure ventilator. II
74. § 868.5955 Intermittent mandatory ventilation attachment. II
75. § 868.5965 Positive end expiratory pressure breathing attachment. II
76. § 868.5400 Electroanesthesia apparatus. III
77. § 868.5610 Membrane lung for long-term pulmonary support. III

4). d. Peralatan Anestesi Lainnya

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 868.6100 Anesthetic cabinet, table, or tray. I
2. § 868.6175 Cardiopulmonary emergency cart. I
3. § 868.6225 Nose clip. I
4. § 868.6400 Calibration gas. I
5. § 868.6700 Anesthesia stool I
6. § 868.6810 Tracheobronchial suction catheter. I
7. § 868.6820 Patient position support. I
8. § 868.6885 Medical gas yoke assembly. I
9. § 868.6250 Portable air compressor. II

5. PERALATAN KARDIOLOGI

5). a. Peralatan Kardiologi Diagnostik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 870.1025 – Arrhythmia detector and alarm (including ST-segment measurement and alarm). II
2. § 870.1100 – Blood pressure alarm. II
3. § 870.1110 – Blood pressure computer. II
4. § 870.1120 – Blood pressure cuff. II
5. § 870.1130 – Noninvasive blood pressure measurement system. II
6. § 870.1140 – Venous blood pressure manometer. II
7. § 870.1200 – Diagnostic intravascular catheter. II
8. § 870.1210 – Continuous flush catheter. II
9. § 870.1220 – Electrode recording catheter or electrode recording probe. II
10. § 870.1230 – Fiberoptic oximeter catheter. II
11. § 870.1240 – Flow-directed catheter. II
12. § 870.1250 – Percutaneous catheter. II
13. § 870.1270 – Intracavitary phonocatheter system. II
14. § 870.1280 – Steerable catheter. II
15. § 870.1290 – Steerable catheter control system. II
16. § 870.1300 – Catheter cannula. II
17. § 870.1310 – Vessel dilator for percutaneous catheterization. II
18. § 870.1330 – Catheter guide wire. II
19. § 870.1340 – Catheter introducer. II
20. § 870.1350 – Catheter balloon repair kit. III
21. § 870.1360 – Trace microsphere. III
22. § 870.1370 – Catheter tip occluder. II
23. § 870.1380 – Catheter stylet. II
24. § 870.1390 – Trocar. II
25. § 870.1425 – Programmable diagnostic computer. II
26. § 870.1435 – Single-function, preprogrammed diagnostic computer. II
27. § 870.1450 – Densitometer. II
28. § 870.1650 – Angiographic injector and syringe. II
29. § 870.1660 – Indicator injector. II
30. § 870.1670 – Syringe actuator for an injector. II
31. § 870.1750 – External programmable pacemaker pulse generator. II
32. § 870.1800 – Withdrawal-infusion pump. II
33. § 870.1875 – Stethoscope. I/II
34. § 870.1915 – Thermodilution probe. II

5). b. Peralatan Kardiologi Pemantauan

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 870.2050 – Biopotential amplifier and signal conditioner. II
2. § 870.2060 – Transducer signal amplifier and conditioner. II
3. § 870.2100 – Cardiovascular blood flowmeter. II
4. § 870.2120 – Extravascular blood flow probe. II
5. § 870.2300 – Cardiac monitor (including cardiotachometer and rate alarm). II
6. § 870.2310 – Apex cardiograph (vibrocardiograph). II
7. § 870.2320 – Ballistocardiograph. II
8. § 870.2330 – Echocardiograph. II
9. § 870.2340 – Electrocardiograph. II
10. § 870.2350 – Electrocardiograph lead switching adaptor. II
11. § 870.2360 – Electrocardiograph electrode. II
12. § 870.2370 – Electrocardiograph surface electrode tester. II
13. § 870.2390 – Phonocardiograph. I
14. § 870.2400 – Vectorcardiograph. II
15. § 870.2450 – Medical cathode-ray tube display. II
16. § 870.2600 – Signal isolation system. I
17. § 870.2620 – Line isolation monitor. I
18. § 870.2640 – Portable leakage current alarm. I
19. § 870.2675 – Oscillometer. II
20. § 870.2700 – Oximeter. II
21. § 870.2710 – Ear oximeter. II
22. § 870.2750 – Impedance phlebograph. II
23. § 870.2770 – Impedance plethysmograph. II
24. § 870.2780 – Hydraulic, pneumatic, or photoelectric plethysmographs. II
25. § 870.2800 – Medical magnetic tape recorder. II
26. § 870.2810 – Paper chart recorder. I
27. § 870.2840 – Apex cardiographic transducer. II
28. § 870.2850 – Extravascular blood pressure transducer. II
29. § 870.2855 – Implantable Intra-aneurysm Pressure Measurement System. II
30. § 870.2860 – Heart sound transducer. II
31. § 870.2870 – Catheter tip pressure transducer. II
32. § 870.2880 – Ultrasonic transducer. II
33. § 870.2890 – Vessel occlusion transducer. II
34. § 870.2900 – Patient transducer and electrode cable (including connector). II
35. § 870.2910 – Radiofrequency physiological signal transmitter and receiver. II
36. § 870.2920 – Telephone electrocardiograph transmitter and receiver. II

5). c. Peralatan Kardiologi Prostetik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 870.3250 – Vascular clip. II
2. § 870.3260 – Vena cava clip. II
3. § 870.3300 – Vascular embolization device. II
4. § 870.3375 – Cardiovascular intravascular filter. II
5. § 870.3450 – Vascular graft prosthesis. II
6. § 870.3470 – Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene. II
7. § 870.3535 – Intra-aortic balloon and control system III
8. § 870.3545 – Ventricular bypass (assist) device. III
9. § 870.3600 – External pacemaker pulse generator. III
10. § 870.3610 – Implantable pacemaker pulse generator. III
11. § 870.3620 – Pacemaker lead adaptor. II
12. § 870.3630 – Pacemaker generator function analyzer. II
13. § 870.3640 – Indirect pacemaker generator function analyzer. II
14. § 870.3650 – Pacemaker polymeric mesh bag. I
15. § 870.3670 – Pacemaker charger. I
16. § 870.3680 – Cardiovascular permanent or temporary pacemaker electrode. II/III
17. § 870.3690 – Pacemaker test magnet. I
18. § 870.3700 – Pacemaker programmers. III
19. § 870.3710 – Pacemaker repair or replacement material. III
20. § 870.3720 – Pacemaker electrode function tester. II
21. § 870.3730 – Pacemaker service tools. I
22. § 870.3800 – Annuloplasty ring. II
23. § 870.3850 – Carotid sinus nerve stimulator. III
24. § 870.3925 – Replacement heart valve. III
25. § 870.3935 – Prosthetic heart valve holder. I
26. § 870.3945 – Prosthetic heart valve sizer. I

5). d. Peralatan Kardiologi Bedah

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 870.4075 – Endomyocardial biopsy device. II
2. § 870.4200 – Cardiopulmonary bypass accessory equipment. II
3. § 870.4205 – Cardiopulmonary bypass bubble detector. II
4. § 870.4210 – Cardiopulmonary bypass vascular catheter, cannula, or tubing. II
5. § 870.4220 – Cardiopulmonary bypass heart-lung machine console. II
6. § 870.4230 – Cardiopulmonary bypass defoamer. II
7. § 870.4240 – Cardiopulmonary bypass heat exchanger. II
8. § 870.4250 – Cardiopulmonary bypass temperature controller. II
9. § 870.4260 – Cardiopulmonary bypass arterial line blood filter. II
10. § 870.4270 – Cardiopulmonary bypass cardiotomy suction line blood filter. II
11. § 870.4280 – Cardiopulmonary prebypass filter. II
12. § 870.4290 – Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting. II
13. § 870.4300 – Cardiopulmonary bypass gas control unit. II
14. § 870.4310 – Cardiopulmonary bypass coronary pressure gauge. II
15. § 870.4320 – Cardiopulmonary bypass pulsatile flow generator. III
16. § 870.4330 – Cardiopulmonary bypass on-line blood gas monitor. II
17. § 870.4340 – Cardiopulmonary bypass level sensing monitor and/or control. II
18. § 870.4350 – Cardiopulmonary bypass oxygenator. II
19. § 870.4360 – Nonroller-type cardiopulmonary bypass blood pump. III
20. § 870.4370 – Roller-type cardiopulmonary bypass blood pump. II
21. § 870.4380 – Cardiopulmonary bypass pump speed control. II
22. § 870.4390 – Cardiopulmonary bypass pump tubing. II
23. § 870.4400 – Cardiopulmonary bypass blood reservoir. II
24. § 870.4410 – Cardiopulmonary bypass in-line blood gas sensor. II
25. § 870.4420 – Cardiopulmonary bypass cardiotomy return sucker. II
26. § 870.4430 – Cardiopulmonary bypass intracardiac suction control. II
27. § 870.4450 – Vascular clamp. II
28. § 870.4475 – Surgical vessel dilator. II
29. § 870.4500 – Cardiovascular surgical instruments. I
30. § 870.4875 – Intraluminal artery stripper. II
31. § 870.4885 – External vein stripper. II

5). e. Peralatan Kardiologi Terapetik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 870.5050 – Patient care suction apparatus. II
2. § 870.5150 – Embolectomy catheter. II
3. § 870.5175 – Septostomy catheter. II
4. § 870.5200 – External cardiac compressor. III
5. § 870.5225 – External counter-pulsating device. III
6. § 870.5300 – DC-defribrillator (including paddles). II/III
7. § 870.5310 – Automated external defibrillator. III
8. § 870.5325 – Defibrillator tester. II
9. § 870.5550 – External transcutaneous cardiac pacemaker (noninvasive). II
10. § 870.5800 – Compressible limb sleeve. II
11. § 870.5900 – Thermal regulating system. II
12. § 870.5925 – Automatic rotating tourniquet. II

6. PERALATAN GIGI

6). a. Peralatan Gigi Diagnostik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 872.1500 – Gingival fluid measurer. I
2. § 872.1720 – Pulp tester. II
3. § 872.1730 – Electrode gel for pulp testers. I
4. § 872.1740 – Caries detection device. II
5. § 872.1745 – Laser fluorescence caries detection device. II
6. § 872.1800 – Extraoral source x-ray system. II
7. § 872.1810 – Intraoral source x-ray system. II
8. § 872.1820 – Dental x-ray exposure alignment device. I
9. § 872.1830 – Cephalometer. II
10. § 872.1840 – Dental x-ray position indicating device. I
11. § 872.1850 – Lead-lined position indicator. I
12. § 872.1870 – Sulfide detection device. II
13. § 872.1905 – Dental x-ray film holder. I
14. § 872.2050 – Dental sonography device. I/II
15. § 872.2060 – Jaw tracking device. I/II

Subpart C [Reserved]

6). b. Peralatan Gigi Prostetik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 872.3050 – Amalgam alloy. II
2. § 872.3060 – Noble metal alloy. II
3. § 872.3080 – Mercury and alloy dispenser. I
4. § 872.3100 – Dental amalgamator. I
5. § 872.3110 – Dental amalgam capsule. I
6. § 872.3130 – Preformed anchor. I
7. § 872.3140 – Resin applicator. I
8. § 872.3150 – Articulator. I
9. § 872.3165 – Precision attachment. I
10. § 872.3200 – Resin tooth bonding agent. II
11. § 872.3220 – Facebow. I
12. § 872.3240 – Dental bur. I
13. § 872.3250 – Calcium hydroxide cavity liner. II
14. § 872.3260 – Cavity varnish. II
15. § 872.3275 – Dental cement. I/II
16. § 872.3285 – Preformed clasp. I
17. § 872.3300 – Hydrophilic resin coating for dentures. II
18. § 872.3310 – Coating material for resin fillings. II
19. § 872.3330 – Preformed crown. I
20. § 872.3350 – Gold or stainless steel cusp. I
21. § 872.3360 – Preformed cusp. I
22. § 872.3400 – Karaya and sodium borate with or without acacia denture adhesive. I/III
23. § 872.3410 – Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive. I
24. § 872.3420 – Carboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive. III
25. § 872.3450 – Ethylene oxide homopolymer and/or karaya denture adhesive. I
26. § 872.3480 – Polyacrylamide polymer (modified cationic) denture adhesive. III
27. § 872.3490 – Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture  adhesive. I
28. § 872.3500 – Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive. III
29. § 872.3520 – OTC denture cleanser. I
30. § 872.3530 – Mechanical denture cleaner. I
31. § 872.3540 – OTC denture cushion or pad. I/II
32. § 872.3560 – OTC denture reliner. II
33. § 872.3570 – OTC denture repair kit. II
34. § 872.3580 – Preformed gold denture tooth. I
35. § 872.3590 – Preformed plastic denture tooth. II
36. § 872.3600 – Partially fabricated denture kit. II
37. § 872.3630 – Endosseous dental implant abutment. II
38. § 872.3640 – Endosseous dental implant. II/III
39. § 872.3645 – Subperiosteal implant material. II
40. § 872.3660 – Impression material. II
41. § 872.3661 – Optical Impression Systems for CAD/CAM. II
42. § 872.3670 – Resin impression tray material. I
43. § 872.3680 – Polytetrafluoroethylene (PTFE) vitreous carbon materials. II
44. § 872.3690 – Tooth shade resin material. II
45. § 872.3700 – Dental mercury. I
46. § 872.3710 – Base metal alloy. II
47. § 872.3730 – Pantograph. I
48. § 872.3740 – Retentive and splinting pin. I
49. § 872.3750 – Bracket adhesive resin and tooth conditioner. II
50. § 872.3760 – Denture relining, repairing, or rebasing resin. II
51. § 872.3765 – Pit and fissure sealant and conditioner. II
52. § 872.3770 – Temporary crown and bridge resin. II
53. § 872.3810 – Root canal post. I
54. § 872.3820 – Root canal filling resin. II/III
55. § 872.3830 – Endodontic paper point. I
56. § 872.3840 – Endodontic silver point. I
57. § 872.3850 – Gutta percha. I
58. § 872.3890 – Endodontic stabilizing splint. II
59. § 872.3900 – Posterior artificial tooth with a metal insert. I
60. § 872.3910 – Backing and facing for an artificial tooth. I
61. § 872.3920 – Porcelain tooth. II
62. § 872.3930 – Bone grafting material. II/III
63. § 872.3940 – Total temporomandibular joint prosthesis. III
64. § 872.3950 – Glenoid fossa prosthesis. III
65. § 872.3960 – Mandibular condyle prosthesis. III
66. § 872.3970 – Interarticular disc prosthesis (interpositional implant). III
67. § 872.3980 – Endosseous dental implant accessories. I

6). c. Peralatan Gigi Bedah

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 872.4120 – Bone cutting instrument and accessories. II
2. § 872.4130 – Intraoral dental drill. I
3. § 872.4200 – Dental handpiece and accessories. I
4. § 872.4465 – Gas-powered jet injector. II
5. § 872.4475 – Spring-powered jet injector. II
6. § 872.4535 – Dental diamond instrument. I
7. § 872.4565 – Dental hand instrument. I
8. § 872.4600 – Intraoral ligature and wire lock. II
9. § 872.4620 – Fiber optic dental light. I
10. § 872.4630 – Dental operating light. I
11. § 872.4730 – Dental injecting needle. I
12. § 872.4760 – Bone plate. II
13. § 872.4840 – Rotary scaler. II
14. § 872.4850 – Ultrasonic scaler. II
15. § 872.4880 – Intraosseous fixation screw or wire. II
16. § 872.4920 – Dental electrosurgical unit and accessories. II

6). d. Peralatan Gigi Terapetik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 872.5410 – Orthodontic appliance and accessories. I
2. § 872.5470 – Orthodontic plastic bracket. II
3. § 872.5500 – Extraoral orthodontic headgear. II
4. § 872.5525 – Preformed tooth positioner. I
5. § 872.5550 – Teething ring. I/II
6. § 872.5570 – Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. II
7. § 872.5580 – Oral rinse to reduce the adhesion of dental plaque. II

6). e. Peralatan Gigi Lainnya

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 872.6010 – Abrasive device and accessories. I
2. § 872.6030 – Oral cavity abrasive polishing agent. I
3. § 872.6050 – Saliva absorber. I
4. § 872.6070 – Ultraviolet activator for polymerization. II
5. § 872.6080 – Airbrush. II
6. § 872.6100 – Anesthetic warmer. I
7. § 872.6140 – Articulation paper. I
8. § 872.6200 – Base plate shellac. I
9. § 872.6250 – Dental chair and accessories. I
10. § 872.6290 – Prophylaxis cup. I
11. § 872.6300 – Rubber dam and accessories. I
12. § 872.6350 – Ultraviolet detector. II
13. § 872.6390 – Dental floss. I
14. § 872.6475 – Heat source for bleaching teeth. I
15. § 872.6510 – Oral irrigation unit. I
16. § 872.6570 – Impression tube. I
17. § 872.6640 – Dental operative unit and accessories. I
18. § 872.6650 – Massaging pick or tip for oral hygiene. I
19. § 872.6660 – Porcelain powder for clinical use. II
20. § 872.6670 – Silicate protector. I
21. § 872.6710 – Boiling water sterilizer. I
22. § 872.6730 – Endodontic dry heat sterilizer. III
23. § 872.6770 – Cartridge syringe. II
24. § 872.6855 – Manual toothbrush. I
25. § 872.6865 – Powered toothbrush. I
26. § 872.6870 – Disposable flouride tray. I
27. § 872.6880 – Preformed impression tray. I
28. § 872.6890 – Intraoral dental wax. I

7. PERALATAN TELINGA, HIDUNG DAN TENGGOROKAN (THT)

7). a. PERALATAN THT DIAGNOSTIK

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 874.1050 – Audiometer. II
2. § 874.1060 – Acoustic chamber for audiometric testing. I
3. § 874.1070 – Short increment sensitivity index (SISI) adapter. I
4. § 874.1080 – Audiometer calibration set. I
5. § 874.1090 – Auditory impedance tester. II
6. § 874.1100 – Earphone cushion for audiometric testing. I
7. § 874.1120 – Electronic noise generator for audiometric testing. II
8. § 874.1325 – Electroglottograph. II
9. § 874.1500 – Gustometer. I
10. § 874.1600 – Olfactory test device. II
11. § 874.1800 – Air or water caloric stimulator. I
12. § 874.1820 – Surgical nerve stimulator/locator. II
13. § 874.1925 – Toynbee diagnostic tube. I

Subpart C [Reserved]

7). b. Peralatan THT Prostetik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 874.3300 – Hearing Aid. I/II
2. § 874.3310 – Hearing aid calibrator and analysis system. II
3. § 874.3320 – Group hearing aid or group auditory trainer. II
4. § 874.3330 – Master hearing aid. II
5. § 874.3375 – Battery-powered artificial larynx. I
6. § 874.3400 – Tinnitus masker. II
7. § 874.3430 – Middle ear mold. II
8. § 874.3450 – Partial ossicular replacement prosthesis. II
9. § 874.3495 – Total ossicular replacement prosthesis. II
10. § 874.3540 – Prosthesis modification instrument for ossicular replacement surgery. I
11. § 874.3620 – Ear, nose, and throat synthetic polymer material. II
12. § 874.3695 – Mandibular implant facial prosthesis. II
13. § 874.3730 – Laryngeal prosthesis (Taub design). II
14. § 874.3760 – Sacculotomy tack (Cody tack) II
15. § 874.3820 – Endolymphatic shunt. II
16. § 874.3850 – Endolymphatic shunt tube with valve. II
17. § 874.3880 – Tympanostomy tube. II
18. § 874.3900 – Nasal dilator. I
19. § 874.3930 – Tympanostomy tube with semipermeable membrane. II
20. § 874.3950 – Transcutaneous air conduction hearing aid system. II

7). c. Peralatan THT Bedah

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 874.4100 – Epistaxis balloon. I
2. § 874.4140 – Ear, nose, and throat bur. I
3. § 874.4175 – Nasopharyngeal catheter. I
4. § 874.4250 – Ear, nose, and throat electric or pneumatic surgical drill. II
5. § 874.4350 – Ear, nose, and throat fiberoptic light source and carrier. I
6. § 874.4420 – Ear, nose, and throat manual surgical instrument. I
7. § 874.4490 – Argon laser for otology, rhinology, and laryngology. II
8. § 874.4500 – Ear, nose, and throat microsurgical carbon dioxide laser. II
9. § 874.4680 – Bronchoscope (flexible or rigid) and accessories. II
10. § 874.4710 – Esophagoscope (flexible or rigid) and accessories. II
11. § 874.4720 – Mediastinoscope and accessories. II
12. § 874.4750 – Laryngostroboscope. I
13. § 874.4760 – Nasopharyngoscope (flexible or rigid) and accessories. II
14. § 874.4770 – Otoscope. I
15. § 874.4780 – Intranasal splint. I
16. § 874.4800 – Bone particle collector. I

7). d. Peralatan THT Terapetik

(NO.CFR) (JENIS PRODUK) (KELAS)

§ 874.5220 – Ear, nose, and throat drug administration device. I
§ 874.5300 – Ear, nose, and throat examination and treatment unit. I
§ 874.5350 – Suction antichoke device. III
§ 874.5370 – Tongs antichoke device. III
§ 874.5550 – Powered nasal irrigator. I
§ 874.5800 – External nasal splint. I
§ 874.5840 – Antistammering device. I

8. PERALATAN GASTROENTEROLOGI DAN UROLOGI (GU)

8). a. Peralatan GU Diagnostik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 876.1075 – Gastroenterology-Urology Biopsy Instrument I/II
2. § 876.1300 – Ingestible telemetric gastrointestinal capsule imaging System II
3. § 876.1400 – Stomach pH Electrode I
4. § 876.1500 – Endoscope and Accessories I/II
5. § 876.1620 – Urodynamics measurement system II
6. § 876.1725 – Gastrointestinal motility monitoring system II
7. § 876.1735 – Electrogastrography system II
8. § 876.1800 – Urine flow or volume measuring system II

8). b. Peralatan GU Pemantauan

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 876.2040 – Enuresis alarm. II
2. 8.3 Peralatan GU Prostetik
3. § 876.3350 – Penile inflatable implant. III
4. § 876.3630 – Penile rigidity implant. II
5. § 876.3750 – Testicular prosthesis. III

8). c. Peralatan GU Prostetik

8). d. Peralatan GU Bedah

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 876.4020 – Fiberoptic light ureteral catheter. II
2. § 876.4270 – Colostomy rod. II
3. § 876.4300 – Endoscopic electrosurgical unit and accessories. II
4. § 876.4370 – Gastroenterology-urology evacuator. I/II
5. § 876.4400 – Hemorrhoidal ligator. II
6. § 876.4480 – Electrohydraulic lithotriptor. II
7. § 876.4500 – Mechanical lithotriptor. II
8. § 876.4530 – Gastroenterology-urology fiberoptic retractor. I
9. § 876.4560 – Ribdam. I
10. § 876.4590 – Interlocking urethral sound. I
11. § 876.4620 – Ureteral stent. II
12. § 876.4650 – Water jet renal stone dislodger system. II
13. § 876.4680 – Ureteral stone dislodger. II
14. § 876.4730 – Manual gastroenterology-urology surgical instrument and accessories. I
15. § 876.4770 – Urethrotome. II
16. § 876.4890 – Urological table and accessories. I/II

8). e. Peralatan GU Terapetik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 876.5010 – Biliary catheter and accessories. II
2. § 876.5020 – External penile rigidity devices. II
3. § 876.5030 – Continent ileostomy catheter. I
4. § 876.5090 – Suprapubic urological catheter and accessories. I/II
5. § 876.5130 – Urological catheter and accessories. I/II
6. § 876.5160 – Urological clamp for males. I
7. § 876.5210 – Enema kit. I
8. § 876.5220 – Colonic irrigation system. II/III
9. § 876.5250 – Urine collector and accessories. I/II
10. § 876.5270 – Implanted electrical urinary continence device. III
11. § 876.5280 – Implanted mechanical/hydraulic urinary continence device. III
12. § 876.5310 – Nonimplanted, peripheral electrical continence device. II
13. § 876.5320 – Nonimplanted electrical continence device. II
14. § 876.5365 – Esophageal dilator. II
15. § 876.5450 – Rectal dilator. I
16. § 876.5470 – Ureteral dilator. II
17. § 876.5520 – Urethral dilator. I/II
18. § 876.5540 – Blood access device and accessories. I/II/III
19. § 876.5600 – Sorbent regenerated dialysate delivery system for hemodialysis. II
20. § 876.5630 – Peritoneal dialysis system and accessories. II
21. § 876.5665 – Water purification system for hemodialysis. II
22. § 876.5820 – Hemodialysis system and accessories. I/II
23. § 876.5830 – Hemodialyzer with disposable insert (Kiil type). II
24. § 876.5860 – High permeability hemodialysis system. II
25. § 876.5870 – Sorbent hemoperfusion system. III
26. § 876.5880 – Isolated kidney perfusion and transport system and accessories. II
27. § 876.5885 – Tissue culture media for human ex vivo tissue and cell culture processing applications II
28. § 876.5895 – Ostomy irrigator. II
29. § 876.5900 – Ostomy pouch and accessories. I
30. § 876.5920 – Protective garment for incontinence. I
31. § 876.5955 – Peritoneo-venous shunt. II
32. § 876.5970 – Hernia support. I
33. § 876.5980 – Gastrointestinal tube and accessories. I/II
34. § 876.5990 – Extracorporeal shock wave lithotripter. II

9. PERALATAN RUMAH SAKIT UMUM DAN PERORANGAN

9). a. Peralatan RSU & P Pemantauan

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 880.2200 – Liquid crystal forehead temperature strip. 2
2. § 880.2400 – Bed-patient monitor. 1
3. § 880.2420 – Electronic monitor for gravity flow infusion systems. 2
4. § 880.2460 – Electrically powered spinal fluid pressure monitor. 2
5. § 880.2500 – Spinal fluid manometer. 2
6. § 880.2700 – Stand-on patient scale. 1
7. § 880.2720 – Patient scale. 1
8. § 880.2740 – Surgical sponge scale. 1
9. § 880.2800 – Sterilization process indicator. 2
10. § 880.2900 – Clinical color change thermometer. 1
11. § 880.2910 – Clinical electronic thermometer. 2
12. § 880.2920 – Clinical mercury thermometer. 2
13. § 880.2930 – Apgar timer. 1

9). b. Peralatan RSU & P Terapetik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 880.5025 – I.V. container. 2
2. § 880.5045 – Medical recirculating air cleaner. 2
3. § 880.5075 – Elastic bandage. 1
4. § 880.5090 – Liquid bandage. 1
5. § 880.5100 – AC-powered adjustable hospital bed. 2
6. § 880.5110 – Hydraulic adjustable hospital bed. 1
7. § 880.5120 – Manual adjustable hospital bed. 1
8. § 880.5130 – Infant radiant warmer. 2
9. § 880.5140 – Pediatric hospital bed. 2
10. § 880.5150 – Nonpowered flotation therapy mattress. 1
11. § 880.5160 – Therapeutic medical binder. 1
12. § 880.5180 – Burn sheet. 1
13. § 880.5200 – Intravascular catheter. 2
14. § 880.5210 – Intravascular catheter securement device. 1
15. § 880.5240 – Medical adhesive tape and adhesive bandage. 1
16. § 880.5270 – Neonatal eye pad. 1
17. § 880.5300 – Medical absorbent fiber. 1
18. § 880.5400 – Neonatal incubator. 2
19. § 880.5410 – Neonatal transport incubator. 2
20. § 880.5420 – Pressure infusor for an I.V. bag. 1
21. § 880.5430 – Nonelectrically powered fluid injector. 2
22. § 880.5440 – Intravascular administration set. 2
23. § 880.5450 – Patient care reverse isolation chamber. 2
24. § 880.5475 – Jet lavage. 2
25. § 880.5500 – AC-powered patient lift. 2
26. § 880.5510 – Non-AC-powered patient lift. 1
27. § 880.5550 – Alternating pressure air flotation mattress. 2
28. § 880.5560 – Temperature regulated water mattress. 1
29. § 880.5570 – Hypodermic single lumen needle. 2
30. § 880.5580 – Acupuncture needle. 2
31. § 880.5630 – Nipple shield. 1
32. § 880.5640 – Lamb feeding nipple. 1
33. § 880.5680 – Pediatric position holder. 1
34. § 880.5700 – Neonatal phototherapy unit. 2
35. § 880.5725 – Infusion pump. 2
36. § 880.5740 – Suction snakebite kit. 1
37. § 880.5760 – Chemical cold pack snakebite kit. 3
38. § 880.5780 – Medical support stocking. 2
39. § 880.5820 – Therapeutic scrotal support. 1
40. § 880.5860 – Piston syringe. 2
41. § 880.5950 – Umbilical occlusion device. 1
42. § 880.5960 – Lice removal kit. 1
43. § 880.5965 – Subcutaneous, implanted, intravascular infusion port and catheter. 2
44. § 880.5970 – Percutaneous, implanted, long-term intravascular catheter. 2

9). c. Peralatan RSU & P Lainnya

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 880.6025 – Absorbent tipped applicator. 1
2. § 880.6050 – Ice bag. 1
3. § 880.6060 – Medical disposable bedding. 1
4. § 880.6070 – Bed board. 1
5. § 880.6080 – Cardiopulmonary resuscitation board. 1
6. § 880.6085 – Hot/cold water bottle. 1
7. § 880.6100 – Ethylene oxide gas aerator cabinet. 2
8. § 880.6140 – Medical chair and table. 1
9. § 880.6150 – Ultrasonic cleaner for medical instruments. 1
10. § 880.6175 – [Reserved]
11. § 880.6185 – Cast cover. 1
12. § 880.6190 – Mattress cover for medical purposes. 1
13. § 880.6200 – Ring cutter. 1
14. § 880.6230 – Tongue depressor. 1
15. § 880.6250 – Patient examination glove. 1
16. § 880.6260 – Filtering facepiece respirator for use by the general public in public health medical emergencies. 1
17. § 880.6265 – Examination gown. 1
18. § 880.6280 – Medical insole 1
19. § 880.6300 – Implantable radio frequency transponder system for patient identification and health information 2
20. § 880.6320 – AC-powered medical examination light 1
21. § 880.6350 – Battery powered medical examination light 1
22. § 880.6375 – Patient lubricant 1
23. § 880.6430 – Liquid medication dispenser 1
24. § 880.6450 – Skin pressure protectors 1
25. § 880.6500 – Medical ultraviolet air purifier 2
26. § 880.6710 – Medical ultraviolet water purifier 2
27. § 880.6770 – Body waste receptacle 1
28. § 880.6740 – Vacuum powered body fluid suction apparatus 2
29. § 880.6760 – Protective restraint 1
30. § 880.6775 – Powered patient transfer device 2
31. § 880.6785 – Manual patient transfer device 1
32. § 880.6800 – Washers for body waste receptacle 1
33. § 880.6820 – Medical disposable scissors 1
34. § 880.6850 – Sterilization wrap 2
35. § 880.6860 – Ethylen oxide gas sterilization 2
36. § 880.6870 – Dry heat sterilization 2
37. § 880.6880 – Steam sterilization 2
38. § 880.6885 – Liquid chemical sterilants/ high level desinfectan 2
39. § 880.6890 – General purpose desinfectants 1
40. § 880.6900 – Hand carried stretcher 1
41. § 880.6910 – Wheeled stretcher 2
42. § 880.6960 – Irrigating syringe 1
43. § 880.6970 – Liquid crystal vein locator 1
44. § 880.6980 – Vein stabilizer 1
45. § 880.6990 – Infusion stand 1
46. § 880.6991 – Medical washer 2
47. § 880.6992 – Medical washer-disinfector 2

10. NEUROLOGICAL DEVICES

10). a. Peralatan Neurologi Diagnostik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 882.1020 – Rigidity analyzer. 2
2. § 882.1030 – Ataxiagraph. 1
3. § 882.1200 – Two-point discriminator. 1
4. § 882.1240 – Echoencephalograph. 2
5. § 882.1275 – Electroconductive media. 2
6. § 882.1310 – Cortical electrode. 2
7. § 882.1320 – Cutaneous electrode. 2
8. § 882.1330 – Depth electrode. 2
9. § 882.1340 – Nasopharyngeal electrode. 2
10. § 882.1350 – Needle electrode. 2
11. § 882.1400 – Electroencephalograph. 1
12. § 882.1410 – Electroencephalograph electrode/lead tester. 1
13. § 882.1420 – Electroencephalogram (EEG) signal spectrum analyzer. 1
14. § 882.1430 – Electroencephalograph test signal generator. 2
15. § 882.1460 – Nystagmograph. 2
16. § 882.1480 – Neurological endoscope. 1
17. § 882.1500 – Esthesiometer. 1
18. § 882.1525 – Tuning fork. 2
19. § 882.1540 – Galvanic skin response measurement device. 2
20. § 882.1550 – Nerve conduction velocity measurement device. 2
21. § 882.1560 – Skin potential measurement device. 2
22. § 882.1570 – Powered direct-contact temperature measurement device. 2
23. § 882.1610 – Alpha monitor. 2
24. § 882.1620 – Intracranial pressure monitoring device. 2
25. § 882.1700 – Percussor. 1
26. § 882.1750 – Pinwheel. 1
27. § 882.1790 – Ocular plethysmograph. 3
28. § 882.1825 – Rheoencephalograph. 3
29. § 882.1835 – Physiological signal amplifier. 2
30. § 882.1845 – Physiological signal conditioner. 2
31. § 882.1855 – Electroencephalogram (EEG) telemetry system. 2
32. § 882.1870 – Evoked response electrical stimulator. 2
33. § 882.1880 – Evoked response mechanical stimulator. 2
34. § 882.1890 – Evoked response photic stimulator. 2
35. § 882.1900 – Evoked response auditory stimulator. 2
36. § 882.1925 – Ultrasonic scanner calibration test block. 1
37. § 882.1950 – Tremor transducer. 2

10). b. Peralatan Neurologi Bedah

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 882.4030 – Skull plate anvil. 1
2. § 882.4060 – Ventricular cannula. 1
3. § 882.4100 – Ventricular catheter. 2
4. § 882.4125 – Neurosurgical chair. 1
5. § 882.4150 – Scalp clip. 2
6. § 882.4175 – Aneurysm clip applier. 2
7. § 882.4190 – Clip forming/cutting instrument. 1
8. § 882.4200 – Clip removal instrument. 1
9. § 882.4215 – Clip rack. 1
10. § 882.4250 – Cryogenic surgical device. 2
11. § 882.4275 – Dowel cutting instrument. 2
12. § 882.4300 – Manual cranial drills, burrs, trephines, and their accessories 2
13. § 882.4305 – Powered compound cranial drills, burrs, trephines, and their accessories. 2
14. § 882.4310 – Powered simple cranial drills, burrs, trephines, and their accessories. 2
15. § 882.4325 – Cranial drill handpiece (brace). 1
16. § 882.4360 – Electric cranial drill motor. 2
17. § 882.4370 – Pneumatic cranial drill motor. 2
18. § 882.4400 – Radiofrequency lesion generator. 2
19. § 882.4440 – Neurosurgical headrests. 1
20. § 882.4460 – Neurosurgical head holder (skull clamp). 2
21. § 882.4500 – Cranioplasty material forming instrument. 1
22. § 882.4525 – Microsurgical instrument. 1
23. § 882.4535 – Nonpowered neurosurgical instrument. 1
24. § 882.4545 – Shunt system implantation instrument. 1
25. § 882.4560 – Stereotaxic instrument. 2
26. § 882.4600 – Leukotome. 1
27. § 882.4650 – Neurosurgical suture needle. 1
28. § 882.4700 – Neurosurgical paddie. 2
29. § 882.4725 – Radiofrequency lesion probe. 2
30. § 882.4750 – Skull punch. 1
31. § 882.4800 – Self-retaining retractor for neurosurgery. 2
32. § 882.4840 – Manual rongeur. 2
33. § 882.4845 – Powered rongeur. 2
34. § 882.4900 – Skullplate screwdriver. 1

10). c. Peralatan Neurologi Terapetik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 882.5030 – Methyl methacrylate for aneurysmorrhaphy. 2
2. § 882.5050 – Biofeedback device. 2
3. § 882.5070 – Bite block. 2
4. § 882.5150 – Intravascular occluding catheter. 3
5. § 882.5175 – Carotid artery clamp. 2
6. § 882.5200 – Aneurysm clip. 2
7. § 882.5225 – Implanted malleable clip. 2
8. § 882.5235 – Aversive conditioning device. 2
9. § 882.5250 – Burr hole cover. 2
10. § 882.5275 – Nerve cuff. 2
11. § 882.5300 – Methyl methacrylate for cranioplasty. 2
12. § 882.5320 – Preformed alterable cranioplasty plate. 2
13. § 882.5330 – Preformed nonalterable cranioplasty plate. 2
14. § 882.5360 – Cranioplasty plate fastener. 2
15. § 882.5500 – Lesion temperature monitor. 2
16. § 882.5550 – Central nervous system fluid shunt and components. 2
17. § 882.5800 – Cranial electrotherapy stimulator. 3
18. § 882.5810 – External functional neuromuscular stimulator. 2
19. § 882.5820 – Implanted cerebellar stimulator. 3
20. § 882.5830 – Implanted diaphragmatic/phrenic nerve stimulator. 3
21. § 882.5840 – Implanted intracerebral/subcortical stimulator for pain relief. 3
22. § 882.5850 – Implanted spinal cord stimulator for bladder evacuation. 3
23. § 882.5860 – Implanted neuromuscular stimulator. 3
24. § 882.5870 – Implanted peripheral nerve stimulator for pain relief. 2
25. § 882.5880 – Implanted spinal cord stimulator for pain relief. 2
26. § 882.5890 – Transcutaneous electrical nerve stimulator for pain relief. 2
27. § 882.5900 – Preformed craniosynostosis strip. 2
28. § 882.5910 – Dura substitute. 2
29. § 882.5940 – Electroconvulsive therapy device. 3
30. § 882.5950 – Neurovascular embolization device. 2
31. § 882.5960 – Skull tongs for traction. 2
32. § 882.5970 – Cranial orthosis. 2
33. § 882.5975 – Human dura mater. 2

11. PERALATAN OBSTETRIK DAN GINEKOLOGI (OG)

11). a. Peralatan OG Diagnostik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 884.1040 – Viscometer for cervical mucus. 1
2. § 884.1050 – Endocervical aspirator. 2
3. § 884.1060 – Endometrial aspirator. 2
4. § 884.1100 – Endometrial brush. 2
5. § 884.1175 – Endometrial suction curette and accessories. 2
6. § 884.1185 – Endometrial washer. 2
7. § 884.1300 – Uterotubal carbon dioxide insufflator and accessories. 2
8. § 884.1425 – Perineometer. 2
9. § 884.1550 – Amniotic fluid sampler (amniocentesis tray). 1
10. § 884.1560 – Fetal blood sampler. 2
11. § 884.1600 – Transabdominal amnioscope (fetoscope) and accessories. 3
12. § 884.1630 – Colposcope. 2
13. § 884.1640 – Culdoscope and accessories. 2/1
14. § 884.1660 – Transcervical endoscope (amnioscope) and accessories. 2
15. § 884.1690 – Hysteroscope and accessories. 2/1
16. § 884.1700 – Hysteroscopic insufflator. 2/1
17. § 884.1720 – Gynecologic laparoscope and accessories. 2/1
18. § 884.1730 – Laparoscopic insufflator.

11). b. Peralatan OG Pemantauan

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 884.2050 – Obstetric data analyzer. 3
2. § 884.2225 – Obstetric-gynecologic ultrasonic imager. 2
3. § 884.2600 – Fetal cardiac monitor. 2
4. § 884.2620 – Fetal electroencephalographic monitor. 3
5. § 884.2640 – Fetal phonocardiographic monitor and accessories. 2
6. § 884.2660 – Fetal ultrasonic monitor and accessories. 2
7. § 884.2675 – Fetal scalp circular (spiral) electrode and applicator. 2
8. § 884.2685 – Fetal scalp clip electrode and applicator. 3
9. § 884.2700 – Intrauterine pressure monitor and accessories. 2
10. § 884.2720 – External uterine contraction monitor and accessories. 2
11. § 884.2730 – Home uterine activity monitor. 2
12. § 884.2740 – Perinatal monitoring system and accessories. 1
13. § 884.2800 – Computerized Labor Monitoring System. 2
14. § 884.2900 – Fetal stethoscope. 1/3
15. § 884.2960 – Obstetric ultrasonic transducer and accessories. 2
16. § 884.2980 – Telethermographic system. 1/3
17. § 884.2982 – Liquid crystal thermographic system. 1/3
18. § 884.2990 – Breast lesion documentation system. 2

11). c. Peralatan OG Prostetik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 884.3200 – Cervical drain. 2
2. § 884.3575 – Vaginal pessary. 2
3. § 884.3650 – Fallopian tube prosthesis. 2
4. § 884.3900 – Vaginal stent. 2

11). d. Peralatan OG Bedah

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 884.4100 – Endoscopic electrocautery and accessories. 2
2. § 884.4120 – Gynecologic electrocautery and accessories. 2
3. § 884.4150 – Bipolar endoscopic coagulator-cutter and accessories. 2
4. § 884.4160 – Unipolar endoscopic coagulator-cutter and accessories. 2
5. § 884.4250 – Expandable cervical dilator. 3
6. § 884.4260 – Hygroscopic Laminaria cervical dilator. 2
7. § 884.4270 – Vibratory cervical dilators. 3
8. § 884.4340 – Fetal vacuum extractor. 2
9. § 884.4400 – Obstetric forceps. 2
10. § 884.4500 – Obstetric fetal destructive instrument. 2
11. § 884.4520 – Obstetric-gynecologic general manual instrument. 1
12. § 884.4530 – Obstetric-gynecologic specialized manual instrument. 2/1
13. § 884.4550 – Gynecologic surgical laser. 2
14. § 884.4900 – Obstetric table and accessories. 2

11). e. Peralatan OG Terapetik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 884.5050 – Metreurynter-balloon abortion system. 3
2. § 884.5070 – Vacuum abortion system. 2
3. § 884.5100 – Obstetric anesthesia set. 2
4. § 884.5150 – Nonpowered breast pump. 1
5. § 884.5160 – Powered breast pump. 2
6. § 884.5225 – Abdominal decompression chamber. 3
7. § 884.5250 – Cervical cap. 2
8. § 884.5300 – Condom. 2
9. § 884.5310 – Condom with spermicidal lubricant. 2
10. § 884.5320 – Glans sheath. 3
11. § 884.5330 – Female condom. 3
12. § 884.5350 – Contraceptive diaphragm and accessories. 2
13. § 884.5360 – Contraceptive intrauterine device (IUD) and introducer. 3
14. § 884.5380 – Contraceptive tubal occlusion device (TOD) and introducer. 3
15. § 884.5390 – Perineal heater. 2
16. § 884.5400 – Menstrual cup. 2
17. § 884.5425 – Scented or scented deodorized menstrual pad. 2
18. § 884.5435 – Unscented menstrual pad. 1
19. § 884.5460 – Scented or scented deodorized menstrual tampon. 2
20. § 884.5470 – Unscented menstrual tampon. 2
21. § 884.5900 – Therapeutic vaginal douche apparatus. 2/1
22. § 884.5920 – Vaginal insufflator. 1
23. § 884.5940 – Powered vaginal muscle stimulator for therapeutic use. 3
24. § 884.5960 – Genital vibrator for therapeutic use. 2
25. § 884.5970 – Clitoral engorgement device. 2

11). f. Peralatan Bantu Reproduksi

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 884.6100 – Assisted reproduction needles. 2
2. § 884.6110 – Assisted reproduction catheters. 2
3. § 884.6120 – Assisted reproduction accessories. 2
4. § 884.6130 – Assisted reproduction microtools. 2
5. § 884.6140 – Assisted reproduction micropipette fabrication instruments. 2
6. § 884.6150 – Assisted reproduction micromanipulators and microinjectors. 2
7. § 884.6160 – Assisted reproduction labware. 2
8. § 884.6170 – Assisted reproduction water and water purification systems. 2
9. § 884.6180 – Reproductive media and supplements. 2
10. § 884.6190 – Assisted reproductive microscopes and microscope accessories. 1
11. § 884.6200 – Assisted reproduction laser system. 2

12. PERALATAN MATA

12). a. Peralatan Mata Diagnostik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 886.1040 Ocular esthesiometer I
2. § 886.1050 Adaptometer (biophotometer) I
3. § 886.1070 Anomaloscope I
4. § 886.1090 Haidinger brush I
5. § 886.1140 Opthalmic chair I
6. § 886.1150 Visual acuity chart I
7. § 886.1160 Color vision plate illuminator I
8. § 886.1170 Color vision tester I
9. § 886.1190 Distometer I
10. § 886.1200 Optokinetic drum I
11. § 886.1250 Euthyscope I
12. § 886.1270 Exophthalmometer I
13. § 886.1290 Fixation device I
14. § 886.1320 Fornixscope I
15. § 886.1330 Amsler grid I
16. § 886.1340 Haploscope I
17. § 886.1350 Keratoscope I
18. § 886.1375 Bagolini lens I
19. § 886.1380 Diagnostic condensing lens I
20. § 886.1390 Flexible diagnostic Fresnel lens I
21. § 886.1395 Diagnostic Hruby fundus lens I
22. § 886.1400 Maddox lens I
23. § 886.1405 Ophthalmic trial lens set I
24. § 886.1410 Ophthalmic trial lens clip I
25. § 886.1415 Ophthalmic trial lens frame I
26. § 886.1420 Ophthalmic lens gauge I
27. § 886.1425 Lens measuring instrument I
28. § 886.1430 Ophthalmic contact lens radius measuring device I
29. § 886.1435 Maxwell spot I
30. § 886.1450 Corneal radius measuring device I
31. § 886.1460 Stereopsis measuring instrument I
32. § 886.1500 Headband mirror I
33. § 886.1605 Perimeter I
34. § 886.1650 Ophthalmic bar prism I
35. § 886.1655 Ophthalmic Fresnel prism I
36. § 886.1660 Gonioscopic prism I
37. § 886.1665 Ophthalmic rotary prism I
38. § 886.1680 Ophthalmic projector I
39. § 886.1690 Pupillograph I
40. § 886.1700 Pupillometer I
41. § 886.1750 Skiascopic rack I
42. § 886.1760 Ophthalmic refractometer I
43. § 886.1770 Manual refractor I
44. § 886.1790 Nearpoint ruler I
45. § 886.1800 Schirmer strip I
46. § 886.1810 Tangent screen (campimeter) I
47. § 886.1840 Simulatan (including crossed cylinder) I
48. § 886.1860 Ophthalmic instrument stand I
49. § 886.1870 Stereoscope I
50. § 886.1880 Fusion and stereoscopic target I
51. § 886.1905 Nystagmus tape I
52. § 886.1910 Spectacle dissociation test system I
53. § 886.1940 Tonometer sterilizer I
54. § 886.1120 Ophthalmic camera II
55. § 886.1220 Corneal electrode II
56. § 886.1300 Afterimage flasher II
57. § 886.1360 Visual field laser instrument II
58. § 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens II
59. § 886.1510 Eye movement monitor II
60. § 886.1570 Ophthalmoscope II
61. § 886.1630 AC-powered photostimulator II
62. § 886.1640 Ophthalmic preamplifier II
63. § 886.1670 Ophthalmic isotope uptake probe II
64. § 886.1780 Retinoscope II
65. § 886.1850 AC-powered slitlamp biomicroscope II
66. § 886.1930 Tonometer and accessories II
67. § 886.1945 Transilluminator II
68. § 886.3200 Artificial eye I
69. § 886.3100 Ophthalmic tantalum clip II
70. § 886.3130 Ophthalmic conformer II
71. § 886.3300 Absorbable implant (scleral buckling method) II
72. § 886.3320 Eye sphere implant II
73. § 886.3340 Extraocular orbital implant II
74. § 886.3800 Scleral shell II
75. § 886.3920 Aqueous shunt II
76. § 886.3320 Eye sphere implant II
77. § 886.3400 Keratoprosthesis II
78. § 886.3600 Intraocular lens III

12). b. Peralatan Mata Prostetik

12). c. Peralatan Mata Bedah

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 886.4070 Powered corneal burr I
2. § 886.4230 Ophthalmic knife test drum I
3. § 886.4300 Intraocular lens guide I
4. § 886.4335 Operating headlamp I
5. § 886.4350 Manual ophtalmic surgical instrument I
6. § 886.4360 Ocular surgery irrigation device I
7. § 886.4370 Keratome I
8. § 886.4445 Permanent magnet I
9. § 886.4570 Ophthalmic surgical marker I
10. § 886.4750 Ophthalmic eye shield I
11. § 886.4770 Ophthalmic operating spectacles (loupes) I
12. § 886.4855 Ophthalmic instrument table I
13. § 886.4100 Radiofrequencyelectrosurgical cautery apparatus II
14. § 886.4115 Thermal cautery unit II
15. § 886.4150 Vitreous aspiration and cutting instrument II
16. § 886.4170 Cryophthalmic unit II
17. § 886.4250 Ophthalmic electrolysis unit II
18. § 886.4390 Ophthalmic laser II
19. § 886.4392 Nd:YAG laser for posterior capsulotomy and peripheral iridotomy II
20. § 886.4400 Electronic metal locator II
21. § 886.4440 AC powered magnet II
22. § 886.4610 Ocular pressure applicator II
23. § 886.4670 Phacofragmentation system II
24. § 886.4690 Opthalmic photocoagulator II
25. § 886.4790 Ophthalmic sponge II
26. § 886.4270 Intraocular gas III
27. § 886.4275 Intraocular fluid III
28. § 886.4280 Intraocular pressure measuring device III

12). d. Peralatan Mata Terapetik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 886.5120 Low-power binocular loupe I
2. § 886.5420 Contact lens inserter/remover I
3. § 886.5540 Low-vision magnifier I
4. § 886.5600 Ptosis crutch I
5. § 886.5800 Ophthalmic bar reader I
6. § 886.5810 Ophthalmic prism reader I
7. § 886.5820 Closed-cicuit televion reading system I
8. § 886.5840 Magnifying spectacles I
9. § 886.5842 Spectacle frame I
10. § 886.5844 Prescription spectacle lens I
11. § 886.5850 Sunglasses (nonprescription) I
12. § 886.5870 Low-vision telescope I
13. § 886.5900 Electronic vision aid I
14. § 886.5910 Image intensification vision aid I
15. § 886.5915 Optical vision aid I
16. § 886.5100 Ophthalmic beta radiation source II
17. § 886.5916 Rigid gas permeable contact lens II
18. § 886.5918 Rigid gas permeable contact lens products II
19. § 886.5925 Soft (hydrophilic) contact lens II
20. § 886.5928 Soft (hydrophilic) contact lens care products II

13. PERALATAN ORTOPEDI

13). a Peralatan Ortopedi Diagnostik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 888.1100 Arthroscope I
2. § 888.1500 Goniometer I
3. § 888.1520 Nonpowered Goniometer I
4. § 888.1240 AC-powered dynamometer II

13). b. Peralatan Ortopedi Prostetik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 888.3000 Bone cap I
2. § 888.3010 Bone fixation cerclage II
3. § 888.3020 Intramedullary fixation rod II
4. § 888.3025 Passive tendon prosthesis II
5.                         Polymethylmethacrylate (PMMA) bone cement II
6. § 888.3030 Single/multiple component metalic bone fixation appliances and accessories II
7. § 888.3040 Smooth or threaded metalic bone fixation fastener II
8.                          Resorbable calcium salt bone void filler device II
9. § 888.3050 Spinal interlaminal fixation orthosis II
10. § 888.3060 Spinal intervertebral body fixation orthosis II
11. § 888.3070 Pedicle screw spinal system II/III
12. § 888.3100 Ankle joint metal/composite semi-constrained cemented prosthesis II
13. § 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis II
14. § 888.3150 Elbow joint metal/polymer constrained cemented prosthesis II
15. § 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis II
16. § 888.3170 Elbow joint radial (hemielbow) polymer prosthesis II
17. § 888.3230 Finger joint polymer constrained prosthesis II
18.                         Hip joint metal/polymer constrained cemented or uncemented prosthesis II
19. § 888.3340 Hip joint metal/composite semi-constrained cemented prosthesis II
20. § 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis II
21. § 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncement prothesis II
22. § 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis II
23. § 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis II
24. § 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis II
25. § 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis II
26. § 888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis II
27. § 888.3530 Knee joint femorotibial metal/composite semi- constrained cemented prosthesis II
28. § 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis II
29. § 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis II
30. § 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis II
31. § 888.3560 Knee joint patellofemoral polymer/metal/polymer semi-constrained cemented prosthesis II
32.                          Knee joint patellofemoral polymer/polymer semi-constrained uncemented prosthesis II
33. § 888.3580 Knee joint patellar (hemi-knee) metallic resurfacing un-cemented prosthesis II
34. § 888.3590 Knee joint tibial (hemi-knee) metallic resurfacing un-cemented prosthesis II
35. § 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis II
36. § 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis II
37. § 888.3670 Shoulder joint metal/polymer nonconstrained or semiconstrained porous-coated uncemented prosthesis II
38. § 888.3690 Shoulder joint humeral (hemi-shoulder) metallic un-cemented prosthesis II
39. § 888.3720 Toe joint polymer constrained prosthesis II
40. § 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis II
41. § 888.3750 Wrist joint carpal lunate polymer prosthesis II
42. § 888.3760 Wrist joint carpal scaphoid polymer prosthesis II
43. § 888.3770 Wrist joint carpal trapezium polymer prosthesis II
44. § 888.3780 Wrist joint polymer constrained prosthesis II
45. § 888.3800 Wrist joint metal/polymer semi constrained cement prosthesis II
46. § 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis II
47. § 888.3015 Bone heterograft III
48. § 888.3027 Polymethylmethacrylate (PMMA) bone cement III
49. § 888.3120 Ankle joint metal/polymer non-constrained cemented prosthesis III
50.                         Elbow joint metal/metal or metal/polymer constrained cemented prosthesis III
51. § 888.3180 Elbow joint humeral (hemielbow) metalic uncemented prosthesis III
52. § 888.3200 Finger joint metal/metal constrained uncemented prosthesis III
53. § 888.3210 Finger joint metal/metal constrained cemented prosthesis III
54. § 888.3220 Finger joint metal/polymer constrained cemented prosthesis III
55. § 888.3300 Hip joint metal constrained cemented or uncemented prosthesis III
56. § 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis III
57. § 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis III
58. § 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, III
59. § 888.3370 Hip joint (hemi-hip) acetabular metal cemented prosthesis III
60. § 888.3380 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis III
61. Hip joint femoral metal/polymer resurfacing cemented prosthesis III
62. § 888.3480 Knee joint femorotibial metallic constrained cemented prosthesis III
63. § 888.3540 Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis III
64. § 888.3550 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis III
65. § 888.3570 Knee joint ofemoral (hemi-knee) metallic uncemented prosthesis III
66. § 888.3580 Knee joint patellofemoral polymer/metal/metal constrained cemented prosthesis III
67. § 888.3640 Knee joint patellar (hemi-knee) metallic resurfacing un-cemented prosthesis III
68. § 888.3650 Shoulder joint metal/ polymer non-constrained cemented prosthesis III
69. § 888.3660 Shoulder joint metal/ polymer semi constrained cemented prosthesis III
70. § 888.3680 Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis III
71. § 888.3790 Wrist joint metal constrained cement prosthesis III

13). c. Peralatan Ortopedi Bedah

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 888.4150 Calipers for clinical use I
2. § 888.4200 Cement dispenser I
3. § 888.4210 Cement mixer for clinical use I
4. § 888.4220 Cement monomer vapor evacuator I
5. § 888.4230 Cement ventilator tube I
6. § 888.4300 Depth gauge for clinical use I
7. § 888.4540 Orthopedic manual surgical instrument I
8. § 888.4600 Protractor for clinical use I
9. § 888.4800 Template for clinical use I
10. § 888.5850 Nonpowered orthopedic traction apparatus and accessories I
11. § 888.5890 Noninvasive traction component I
12. § 888.5940 Cast component I
13. § 888.5960 Cast removal instrument I
14. § 888.5980 Manual cast application and removal instrument I
15. § 888.4580 Sonic surgical instrument and accessories/attachments II

14. PERALATAN KESEHATAN FISIK

14). a. Peralatan Kesehatan Fisik Diagnostik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 890.1175 Electrode cable II
2. § 890.1575 Force-measuring platform I
3. § 890.1600 Intermittent presure measurement system I
4. § 890.1615 Miniature presure transducer I
5. § 890.1225 Chronaximeter II
6. § 890.1375 Diagnostic electromyograph II
7. § 890.1385 Diagnostic electromyograph needle electrode II
8. § 890.1450 Powered reflex hammer II
9. § 890.1850 Diagnostic muscle stimulator II
10. § 890.1925 Isokinetic testing and evaluation system II

14). b. Peralatan Kesehatan Fisik Prostetik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 890.3025 Prosthetic and orthotic accessory I
2. § 890.3075 Cane I
3. § 890.3100 Mechanical chair I
4. § 890.3150 Crutch I
5. § 890.3175 Flotation cushion I
6. § 890.3410 External limb orthotic component I
7. § 890.3420 External limb prosthetic component I
8. § 890.3475 Limb orthosis I
9. § 890.3490 Truncal orthosis I
10. § 890.3520 Plinth I
11. § 890.3640 Arm sling I
12. § 890.3665 Congenital hip dislocation abduction splint I
13. § 890.3675 Denis Brown splint I
14. § 890.3700 Nonpowered communication system I
15. § 890.3750 Mechanical table I
16. § 890.3760 Powered table I
17. § 890.3790 Cane, crutch, and walker tips and pads I
18. § 890.3825 Mechanical walker I
19. § 890.3850 Mechanical wheelchair I
20. § 890.3910 Wheelchair accessory I
21. § 890.3920 Wheelchair component I
22. § 890.3940 Wheelchair platform scale I
23. § 890.3110 Electric positioning chair II
24. § 890.3500 External assembled lower limb prosthesis II
25. § 890.3690 Powered wheeled stretcher II
26. § 890.3710 Powered communication system II
27. § 890.3725 Powered environmental control system II
28. § 890.3800 Motorized three-wheeled vehicle II
29. § 890.3860 Powered wheelchair II
30. § 890.3880 Special grade wheelchair II
31. § 890.3900 Standup wheelchair II
32. § 890.3930 Wheelchair elevator II
33. § 890.3610 Rigid pneumatic structure orthosis III
34. § 890.3890 Stair-climbing wheelchair III

14). c. Peratatan Kesehatan Fisik terapetik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 890.5050 Daily activity assist device I
2. § 890.5125 Nonpowered sitz bath I
3. § 890.5180 Manual patient rotation bed I
4. § 890.5350 Exercise component I
5. § 890.5370 Non-measuring exercise equipment I
6. § 890.5380 Powered exercise equipment I
7. § 890.5410 Powered finger exerciser I
8. § 890.5660 Therapeutic massager I
9. § 890.5700 Cold pack I
10. § 890.5710 Hot or Cold disposable pack I
11. § 890.5730 Moist heat pack I
12. § 890.5765 Pressure-applying device I
13. § 890.5925 Traction accessory I
14. § 890.5940 Chilling unit I
15. § 890.5950 Powered heating unit I
16. § 890.5975 Therapeutic vibrator I
17. § 890.5100 Immersion hydrobath II
18. § 890.5110 Paraffin bath II
19. § 890.5150 Powered patient transport II
20. § 890.5160 Air-fluidized bed II
21. § 890.5170 Powered flotation therapy bed II
22. § 890.5225 Powered patient rotation bed II
23. § 890.5250 Moist steam cabinet II
24. § 890.5360 Measuring exercise equipment II
25. § 890.5500 Infrared lamp II
26. § 890.5575 Powered external limb overload warning device II
27. § 890.5650 Powered inflatable tube massager II
28. § 890.5720 Water circulating hot or cold pack II
29. § 890.5740 Powered heating pad II
30. § 890.5850 Powered muscle stimulator II
31. § 890.5880 Multi-function physical therapy table II
32. § 890.5900 Power traction equipment II
33. § 890.5275 Ultrasonic diathermy (for use in applying therapeutic deep heat for selected medical conditions) II
34.                          Microwave diathermy (for all other use) III
35. § 890.5290 Shortwave diathermy (for use in applying therapeutic deep heat for selected medical conditions)  II
36.                          Shortwave diathermy (for all other use) III
37. § 890.5300 Microwave diathermy (for use in applying therapeutic deep heat for selected medical conditions) II
38.                          Ultrasonic diathermy (for all other use) III
39. § 890.5525 Iontophoresis device (Intended for certain specified uses) II
40.                         Iontophoresis device (for all other use) III
41. § 890.5860 Ultrasound and muscle stimulator(for use in applying therapeutic deep heat for selected medical conditions) II
42.                         Ultrasound and muscle stimulator (for all other use) III

15. PERALATAN RADIOLOGI

15). a. Peralatan Radiologi Diagnostik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 892.1100 Scintillation (gamma) camera I
2. § 892.1110 Positron camera I
3. § 892.1130 Nuclear whole body counter I
4. § 892.1300 Nuclear rectilinear scanner I
5. § 892.1320 Nuclear uptake probe I
6. § 892.1330 Nuclear whole body scanner I
7. § 892.1350 Nuclear scanning bed I
8. § 892.1370 Nuclear anthropomorphic phantom I
9. § 892.1380 Nuclear flood source phantom I
10. § 892.1400 Nuclear sealed calibration source I
11. § 892.1410 Nuclear electrocardiograph synchronizer I
12. § 892.1420 Radionuclide test pattern phantom I
13. § 892.1640 Radiographic film marking system I
14. § 892.1700 Diagnostic x-ray high voltage generator I
15. § 892.1760 Diagnostic x-ray tube housing assembly I
16. § 892.1770 Diagnostic x-ray tube mount I
17. § 892.1830 Radiologic patient cradle I
18. § 892.1840 Radiographic film I
19. § 892.1880 Wall-mounted radiographic cassetet holder I
20. § 892.1890 Radiographic film illuminator I
21. § 892.1910 Radiographic grid I
22. § 892.1920 Radiographic head holder I
23. § 892.1940 Radiographic quality assurance instrument I
24. § 892.1950 Radiographic anthropomorphic phantom I
25. § 892.1960 Radiographic intensifying screen I
26. § 892.1970 Radiographic ECG/respirator synchronizer I
27. § 892.2010 Medical image storage device I
28. § 892.2020 Medical image communication device I
29. § 892.1000 Magnetic resonance diagnostic device II
30. § 892.1170 Bone densitometer II
31. § 892.1200 Emission computed tomography system II
32. § 892.1220 Fluorescent scanner II
33. § 892.1310 Nuclear tomography system II
34. § 892.1360 Radionuclide dose calibrator II
35. § 892.1390 Radionuclide rebreathing system II
36. § 892.1540 Nonfetal ultrasonic monitor II
37. § 892.1550 Ultrasonic pulsed doppler imaging system II
38. § 892.1560 Ultrasonic pulsed echo imaging system II
39. § 892.1570 Diagnostic ultrasonic transducer II
40. § 892.1600 Angiographic x-ray system II
41. § 892.1610 Diagnostic x-ray beam limiting device II
42. § 892.1620 Cine or spot fluorographic x-ray camera II
43. § 892.1630 Electrostatic x-ray imaging system II
44. § 892.1650 Image-intensifield fluoroscopic x ray system II
45. § 892.1660 Non-image-intensifield fluoroscopic x ray system II
46. § 892.1670 Spot-film device II
47. § 892.1680 Stationary x-ray system II
48. § 892.1710 Mammographic x-ray system II
49. § 892.1720 Mobile x-ray system II
50. § 892.1730 Photofluorographic x-ray system II
51. § 892.1740 Tomographic x-ray system II
52. § 892.1750 Computed tomography x-ray system II
53. § 892.1820 Peumoencephalographic Chair II
54. § 892.1850 Radiographic film cassette II
55. § 892.1860 Radiographic film/cassette changer II
56. § 892.1870 Radiographic film/cassette changer programmer II
57. § 892.1900 Automatic radiographic film processor II
58. § 892.1980 Radiologic table II
59. § 892.2030 Medical image digitizer II
60. § 892.2040 Medical image hardcopy device II
61. § 892.2050 Picture archiving and communication system II
62. § 892.1990 Transilluminator for breast evaluation III

15). b. Peralatan Radiologi Terapetik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 892.5650 Manual radionuclide applicator system I
2. § 892.5740 Radionuclide teletherapy source I
3. § 892.5780 Light beam patient position indicator I
4. § 892.5050 Medical charge-particle radiation therapy system II
5. § 892.5300 Medical neutron radiation therapy system II
6. § 892.5700 Remote controlled radionuclide applicator system II
7. § 892.5710 Radiation therapy beam-shaping block II
8. § 892.5730 Radionuclide brachytherapy source II
9. § 892.5750 Radionuclide radiation therapy system II
10. § 892.5770 Powered radiation therapy patient support assembly II
11. § 892.5840 Radiation therapy simulation system II
12. § 892.5900 X-ray radiation therapy system II
13. § 892.5930 Therapeutic x-ray tube housing assembly II

15). c. Peralatan Radiologi Lainnya

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 892.6500 Personnel protective shield I

16. PERALATAN BEDAH UMUM DAN BEDAH PLASTIK

16). a. Peralatan Bedah Diagnostik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 878.3250 External facial fracture fixation appliance I
2. § 878.3750 External prosthesis adhesive I
3. § 878.3800 External aesthetic restoration prosthesis I
4. § 878.3900 Inflatable extremity splint I
5. § 878.3910 Noninflatable extremity splint I
6. § 878.3925 Plastic surgery kit and accessories I
7. § 878.3300 Surgical mesh II
8. § 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material II
9. § 878.3550 Chin prosthesis II
10. § 878.3590 Ear prosthesis II
11. § 878.3680 Nose prosthesis II
12. § 878.3530 Silicone inflatable breast prosthesis III
13. § 878.3540 Silicone gel-filled breast prosthesis III
14. § 878.3610 Esophageal prosthesis II
15. § 878.3720 Tracheal prosthesis II

16). b. Peratatan Bedah Prostetik

16). c. Peratatan Bedah

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 878.4014 Nonresorbable gauze/sponge for external use I
2. § 878.4018 Hydrophilic wound dressing I
3. § 878.4020 Occlusive wound dressing I
4. § 878.4022 Hydrogel wound dressing and burn dressing I
5. § 878.4100 Organ bag I
6. § 878.4160 Surgical camera and accessories I
7. § 878.4200 Introduction/drainage catheter and accessories I
8. § 878.4320 Removable skin clip I
9. § 878.4380 Drape adhesive I
10. § 878.4440 Eye pad I
11. § 878.4450 Nonabsorbable gauze for internal use I
12. § 878.4460 Surgeon glove I
13. § 878.4470 Surgeon gloving cream I
14. § 878.4635 Ultraviolet lamp for tanning I
15. § 878.4660 Skin marker I
16. § 878.4680 Nonpowered, single patient, portable suction apparatus I
17. § 878.4700 Surgical microscope and accessories I
18. § 878.4730 Surgical skin degreaser or adhesive tape solvent I
19. § 878.4760 Removable skin staple I
20. § 878.4800 Manual surgical instrument for general use I
21. § 878.4820 Surgical instrument motors and accessories/attachments I
22. § 878.4930 Suture retention device I
23. § 878.4950 Manual operating table and accessories and manual operating chair and accessories I
24. § 878.4960 Operating tables and accessories and operating chairs and accessories I
25. § 878.4025 Silicone Sheeting I
26. § 878.4300 Implantable clip II
27. § 878.4040 Surgical apparel II
28. § 878.4350 Cryosurgical unit and accessories II
29. § 878.4370 Surgical drape and drape accessories II
30. § 878.4400 Electrosurgical cutting and coagulation device and accessories II
31. § 878.4410 Low energy ultrasound wound cleaner II
32. § 878.4493 Absorbable poly(glycolide/L.lactide) surgical suture II
33. § 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology II
34. § 878.4630 Ultraviolet lamp for dermatologic disorders II
35. § 878.4750 Implantable staple II
36. § 878.4780 Powered suction pump II
37. § 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology II
38. § 878.4830 Absorbable surgical gut suture II
39. § 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture II
40. § 878.5010 Nonabsorbable polypropylene surgical suture II
41. § 878.5020 Nonabsorbable polymide surgical suture II
42. § 878.5030 Natural nonabsorbable silk surgical suture II
43. § 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture II
44. § 878.5040 Suction lipoplasty system II
45. § 878.4480 Absorbable powder for lubricanting a surgeon’s glove III
46. § 878.4490 Absorbable hemostatic agent and dressing III
47. § 878.4520 Polytetrafluoroethylene injectable III

16). d. Peratatan Bedah Terapetik

(NO.CFR) (JENIS PRODUK) (KELAS)

1. § 878.5350 Needle-type epilator I
2. § 878.5360 Tweezer-type epilator I
3. § 878.5900 Nonpneumatic tourniquet I
4. § 878.5910 Pneumatic tourniquet I
5. § 878.5070 Air-handling apparatus for a surgical operating room II
6. § 878.5650 Topical oxygen chamber for extremities III

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