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Class I GMP Exempt Procodes -

Reference 9 List of class I devices by product code that FDA has by regulation exempted from the GMP requirements of 21 C F R part 820 Quality System Regulation FDA April 2012

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	GARMENT, STORAGE, PERITONEAL DIALYSIS 
APPLICATOR, ENT DRUG 
EN 
1 
Y 
LXG 
EQUIPMENT, LABORATORY, GENERAL PURPOSE, 
LABELED OR PROMOTED FOR A SPECIFIC MEDICAL 
CH 
1 
Y 
MAU 
ERASER, DENTAL STAIN 
DE 
1 
Y 
MDR 
BINDER, MEDICAL, THERAPEUTIC 
HO 
1 
Y 
MJI 
SPECIMEN/TISSUE, IDENTIFICATION ORIENTATION 
PA 
1 
Y 
MOE 
COLLAGEN CORNEAL SHIELD 
OP 
1 
Y 
MRI 
ORTHOSIS, TRUNCAL/ORTHOSIS, LIMB 
PM 
1 
Y 
MXT 
DEVICE, ACCESSORY, COOLING PLATE FOR TISSUE 
CH 
1 
Y 
NDA 
SHEATH, CORRUGATED RUBBER, FOR NON
JANUS GREEN B 
PA 
1 
Y 
KJX 
JENNER STAIN 
PA 
1 
Y 
KJY 
MALACHITE GREEN 
PA 
1 
Y 
KJZ 
MARTIUS YELLOW 
PA 
1 
Y 
KKA 
KNL 
BOARD, SCOOTER, PRONE 
PM 
1 
Y 
KNO 
ACCESSORIES, WHEELCHAIR 
PM 
1 
Y 
KNP 
ORTHOSIS, CORRECTIVE SHOE 
PM 
1 
Y 
KQC 
STAINS, HEMATOLOGY 
PA 
1 
Y 
KQZ 
COMPONENT, TRACTION, NON-INVASIVE 
OR 
1 
Y 
KTC 
BATH, SITZ, NONPOWERED 
PM 
1 
Y 
KTD 
ORTHOSIS, ABDOMINAL 
PM 
1 
Y 
KXF 
APPLICATOR, ABSORBENT TIPPED, NON-STERILE 
HO 
1 
Y 
KXG 
APPLICATOR, ABSORBENT TIPPED, STERILE 
HO 
1 
Y 
KXR 
APPLICATOR, RESIN 
DE 
1 
Y 
KYR 
BAG, ICE 
HO 
1 
Y 
KYT 
LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED 
HO 
1 
Y 
KYW 
CONTAINER, LIQUID MEDICATION, GRADUATED 
HO 
1 
Y 
KYX 
DISPENSER, LIQUID MEDICATION 
HO 
1 
Y 
KYZ 
SYRINGE, IRRIGATING (NON DENTAL) 
HO 
1 
Y 
KZC 
MANUAL COLONY COUNTER 
MI 
1 
Y 
KZO 
INK, ARCH TRACING 
DE 
1 
Y 
LBJ 
DEVICE, VEIN STABILIZATION 
HO 
1 
Y 
LCN 
SCRAPER, TONGUE 
DE 
1 
Y 
LDT 
REAGENT, GENERAL PURPOSE 
PA 
1 
Y 
LDW 
FIXATIVE, ACID CONTAINING 
PA 
1 
Y 
LDX 
Y 
LED 
STAINS, CHEMICAL SOLUTION 
PA 
1 
Y 
LEE 
STAINS, DYE SOLUTION 
PA 
1 
Y 
LEF 
STAINS, DYE POWDER 
PA 
1 
Y 
LGF 
COMPONENT, CAST 
OR 
1 
Y 
LGG 
INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL 
OR 
1 
Y 
LGY 
TRYPAN BLUE 
PA 
1 
Y 
LHB 
TIMER, APGAR 
HO 
1 
Y 
LHO 
INSTRUMENT, QUALITY-ASSURANCE, RADIOLOGIC 
RA 
1 
Y 
PURIFIER, WATER (ABSORPTION, DEIONIZATION, 
MEMBRANE FILTER, REVERSE OSMOSIS) 
CH 
1 
Y 
JTB 
DEVICE, MEDIA DISPENSING/STACKING 
MI 
1 
Y 
JTM 
ANAEROBIC BOX GLOVE 
MI 
1 
Y 
JTQ 
BATH, INCUBATORS/WATER, ALL 
MI 
1 
Y 
JTS 
STAINS, MICROBIOLOGIC 
PA 
1 
Y 
KCJ 
APPLICATOR, ENT 
EN 
1 
Y 
KCL 
BLOWER, POWDER, ENT 
EN 
1 
Y 
KCM 
DROPPER, ENT 
EN 
1 
Y 
KCN 
EAR WICK 
EN 
1 
Y 
KCO 
INHALER, NASAL 
EN 
1 
Y 
KCP 
SYRINGE, ENT 
EN 
1 
Y 
KCQ 
TUBE IMPRESSION AND MATRIX 
DE 
1 
Y 
KCR 
FACEBOW 
DE 
1 
Y 
KCS 
PANTOGRAPH 
DE 
1 
Y 
KDX 
SOLUTION, DECALCIFIER, ACID CONTAINING 
PA 
1 
Y 
KDY 
AGENT, CHELATING FOR DECALCIFICATION 
PA 
1 
Y 
KDZ 
DEVICE, DECALCIFIER, ELECTROLYTIC 
PA 
1 
Y 
KEE 
KEQ 
MEDIA, MOUNTING, WATER SOLUBLE 
PA 
1 
Y 
KER 
CONTAINER, EMBEDDING 
PA 
1 
Y 
KES 
COVERSLIPS, MICROSCOPE SLIDE 
PA 
1 
Y 
Y 
KJN 
BRILLIANT CRESYL BLUE 
PA 
1 
Y 
KJO 
BRILLIANT GREEN 
PA 
1 
Y 
KJP 
CARMINE 
PA 
1 
Y 
KJQ 
CHLORAZOL BLACK E 
PA 
1 
Y 
KJR 
ERYTHROSIN B 
PA 
1 
Y 
KJS 
HOOK, EXTERNAL LIMB COMPONENT, MECHANICAL 
PM 
1 
Y 
IQZ 
HAND, EXTERNAL LIMB COMPONENT, POWERED 
PM 
1 
Y 
IRA 
HAND, EXTERNAL LIMB COMPONENT, MECHANICAL 
PM 
1 
Y 
IRD 
JOINT, ELBOW, EXTERNAL LIMB COMPONENT, 
MECHANICAL 
PM 
1 
Y 
IRE 
JOINT, ELBOW, EXTERNAL LIMB COMPONENT, 
POWERED 
PM 
1 
Y 
IRS 
HEAD HALTER, TRACTION 
PM 
1 
Y 
ISH 
COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT 
PM 
1 
Y 
ISL 
JOINT, HIP, EXTERNAL LIMB COMPONENT 
PM 
1 
Y 
ISM 
PYLON, POST SURGICAL 
PM 
1 
Y 
ISN 
CABLE 
PM 
1 
Y 
ISP 
VALVE, PROSTHESIS 
PM 
1 
Y 
ISR 
BAND OR BELT, PELVIC SUPPORT 
PM 
1 
Y 
ISS 
IXG 
PHANTOM, ANTHROPOMORPHIC, RADIOGRAPHIC 
RA 
1 
Y 
IXH 
CAMERA, FOCAL SPOT, RADIOGRAPHIC 
RA 
1 
Y 
JBS 
TIMER, GENERAL LABORATORY 
CH 
1 
Y 
JCB 
Y 
JRQ 
SHAKER/STIRRER 
CH 
1 
Y 
JRR 
REGULATOR, TEMPERATURE 
CH 
1 
Y 
GELATIN FOR SPECIMEN ADHESION 
PA 
1 
Y 
IGB 
IME 
PACK, HOT OR COLD, REUSEABLE 
PM 
1 
Y 
IMS 
SUPPORT, HEAD AND TRUNK, WHEELCHAIR 
PM 
1 
Y 
IMX 
BOARD, LAP, WHEELCHAIR 
PM 
1 
Y 
IMY 
ARMBOARD, WHEELCHAIR 
PM 
1 
Y 
IMZ 
HOLDER, CRUTCH AND CANE, WHEELCHAIR 
PM 
1 
Y 
INC 
CUFF, PUSHER, WHEELCHAIR 
PM 
1 
Y 
INE 
SLING, OVERHEAD SUSPENSION, WHEELCHAIR 
PM 
1 
Y 
INF 
SCALE, PLATFORM, WHEELCHAIR 
PM 
1 
Y 
INP 
TIPS AND PADS, CANE, CRUTCH AND WALKER 
PM 
1 
Y 
INT 
PLINTH 
PM 
1 
Y 
IOD 
COMPONENTS, EXERCISE 
PM 
1 
Y 
IOE 
BARS, PARALLEL, EXERCISE 
PM 
1 
Y 
IOG 
TREADMILL, MECHANICAL 
PM 
1 
Y 
ION 
EXERCISER, NON-MEASURING 
PM 
1 
Y 
IOY 
SUPPORT, ARM 
PM 
1 
Y 
IOZ 
SPLINT, ABDUCTION, CONGENITAL HIP DISLOCATION 
PM 
1 
Y 
IPG 
SHOE, CAST 
PM 
1 
Y 
IPM 
COVER, LIMB 
PM 
1 
Y 
IPR 
CRUTCH 
PM 
1 
Y 
IPS 
CANE 
PM 
1 
Y 
IPT 
ORTHOSIS, THORACIC 
PM 
1 
Y 
IPW 
ORTHOSIS, SACROILIAC, SOFT 
PM 
1 
Y 
IPX 
ORTHOSIS, RIB FRACTURE, SOFT 
PM 
1 
Y 
IPY 
ORTHOSIS, LUMBO-SACRAL 
PM 
1 
Y 
IQE 
ORTHOSIS, LUMBAR 
PM 
1 
Y 
IQF 
ORTHOSIS, CERVICAL-THORACIC, RIGID 
PM 
1 
Y 
IQG 
ADAPTOR, HOLDER, SYRINGE 
PM 
Y 
IQI 
ORTHOSIS, LIMB BRACE 
PM 
1 
Y 
IQJ 
SPLINT, CLAVICLE 
PM 
1 
Y 
IQK 
ORTHOSIS, CERVICAL 
PM 
1 
Y 
IQM 
SPLINT, TEMPORARY TRAINING 
PM 
1 
Y 
IQO 
DEVICE, PROSTHESIS ALIGNMENT 
PM 
1 
Y 
IQP 
ROTATOR, TRANSVERSE 
PM 
1 
Y 
IQQ 
JOINT, SHOULDER, EXTERNAL LIMB COMPONENT 
PM 
1 
Y 
IQW 
HOOK, EXTERNAL LIMB COMPONENT, POWERED 
PM 
1 
Y 
SYRUP, GUM, APATHY'S 
PA 
1 
Y 
IAW 
COLLODION 
PA 
1 
Y 
IAY 
COLCHICINE 
PA 
1 
Y 
IBB 
PHYTOHEMAGLUTININ M 
PA 
1 
Y 
IBJ 
LIGHT, MICROSCOPE 
PA 
1 
Y 
IBK 
MICROSCOPE, FLUORESCENCE/U.V. 
PA 
1 
Y 
IBL 
MICROSCOPE, INVERTED STAGE, TISSUE CULTURE 
PA 
1 
Y 
IBM 
MICROSCOPE, PHASE CONTRAST 
PA 
1 
Y 
ICC 
EOSIN B 
PA 
1 
Y 
ICD 
DARROW RED 
PA 
1 
Y 
ICF 
IDB 
ALDEHYDE FUCHSIN 
PA 
1 
Y 
IDC 
ACRIDINE ORANGE 
PA 
1 
Y 
IDD 
ALIZARIN RED 
PA 
1 
Y 
IDE 
ACID, HEMATEIN 
PA 
1 
Y 
IDF 
ACID, FUCHSIN 
PA 
1 
Y 
IDL 
MICROTOME, ACCESSORIES 
PA 
1 
Y 
IDM 
MICROTOME, ULTRA 
PA 
1 
Y 
IDN 
MICROTOME, FREEZING ATTACHMENT 
PA 
1 
Y 
IDO 
MICROTOME, ROTARY 
PA 
1 
Y 
IDP 
MICROTOME, CRYOSTAT 
PA 
1 
Y 
IDQ 
INFILTRATOR 
PA 
1 
Y 
IDR 
OVENS, PARAFFIN 
PA 
1 
Y 
IDS 
MELTING POT, PARAFFIN 
PA 
1 
Y 
IDT 
APPARATUS, MELTING POINT, PARAFFIN 
PA 
1 
Y 
IDW 
DISPENSERS, PARAFFIN 
PA 
1 
Y 
IDX 
SIEVES, TISSUE 
PA 
1 
Y 
IDY 
BATH, FLOTATION, TISSUE 
PA 
1 
Y 
IDZ 
Y 
IFL 
1 
Y 
HYS 
LIGHT GREEN 
PA 
1 
Y 
HYT 
LUXOL FAST BLUE 
PA 
1 
Y 
HYW 
STAIN, TRICHROME, MALLORY'S 
PA 
1 
Y 
HYY 
PA 
1 
Y 
IAB 
TOLUIDINE BLUE 
PA 
1 
Y 
IAC 
VAN GIESON'S STAIN 
PA 
1 
Y 
IAD 
VAN GIESON'S PICRO-FUCHSIN 
PA 
1 
Y 
IAE 
HEMATOXYLIN, IRON, WEIGERT'S 
PA 
1 
Y 
IAF 
WRIGHT'S STAIN 
PA 
1 
Y 
IAL 
IODINE (TINCTURE) 
PA 
1 
Y 
IAM 
SOLUTION, LUGOL'S 
PA 
1 
Y 
BINDER, PERINEAL 
HO 
1 
Y 
FQL 
STOCKING, MEDICAL SUPPORT (FOR GENERAL 
MEDICAL PURPOSES) 
HO 
1 
Y 
FQM 
BANDAGE, ELASTIC 
HO 
1 
Y 
FRI 
SCALE, STAND-ON, PATIENT 
HO 
1 
Y 
FRJ 
CHAIR, GERIATRIC 
HO 
1 
Y 
FRK 
CHAIR, EXAMINATION AND TREATMENT 
HO 
1 
Y 
FRL 
FIBER, MEDICAL, ABSORBENT 
HO 
1 
Y 
FRP 
HOLDER, INFANT POSITION 
HO 
1 
Y 
FSD 
BINDER, ABDOMINAL 
HO 
1 
Y 
FTZ 
HJL 
LENS, CONDENSING, DIAGNOSTIC 
OP 
1 
Y 
HJR 
STEREOSCOPE, BATTERY-POWERED 
OP 
1 
Y 
HJX 
READER, PRISM, OPHTHALMIC 
OP 
1 
Y 
HJY 
READER, BAR, OPHTHALMIC 
OP 
1 
Y 
HJZ 
CRUTCH, PTOSIS 
OP 
1 
Y 
HKB 
TELESCOPE, HAND-HELD, LOW-VISION 
OP 
1 
Y 
HKC 
SPECTACLE MICROSCOPE, LOW-VISION 
OP 
1 
Y 
HKD 
TAPE, NYSTAGMUS 
OP 
1 
Y 
HKG 
FORNIXSCOPE 
OP 
1 
Y 
HKK 
TELESCOPE, SPECTACLE, LOW-VISION 
OP 
1 
Y 
HKM 
HMS 
DRUM, EYE KNIFE TEST 
OP 
1 
Y 
HOH 
SPECTACLE, OPERATING (LOUPE), OPHTHALMIC 
OP 
1 
Y 
HON 
H'HYLFH5HJXODWRU\
Y 
EIE 
DAM, RUBBER 
DE 
1 
Y 
EJE 
FRAME, RUBBER DAM 
DE 
1 
Y 
EJG 
FORCEPS, RUBBER DAM CLAMP 
DE 
1 
Y 
EJP 
ARTICULATORS 
DE 
1 
Y 
EJQ 
WHEEL, POLISHING AGENT 
DE 
1 
Y 
EPE 
BRUSH, CLEANING, TRACHEAL TUBE 
AN 
1 
Y 
EPN 
PUMP, NEBULIZER, MANUAL 
EN 
1 
Y 
EXM 
TRUSS, UMBILICAL 
GU 
1 
Y 
EXN 
SUPPORT, HERNIA 
GU 
1 
Y 
EYQ 
GARMENT, PROTECTIVE, FOR INCONTINENCE 
GU 
1 
Y 
FCE 
ENEMA KIT, (FOR CLEANING PURPOSE) 
GU 
1 
Y 
FLH 
WASHER OF BODY WASTE RECEPTACLES 
HO 
1 
Y 
FMA 
DEPRESSOR, TONGUE, NON-SURGICAL 
HO 
1 
Y 
FME 
GOWN, EXAMINATION 
HO 
1 
Y 
FML 
CHAIR, BLOOD DONOR 
HO 
1 
Y 
FMP 
PROTECTOR, SKIN PRESSURE 
HO 
1 
Y 
FMR 
DEVICE, TRANSFER, PATIENT, MANUAL 
HO 
1 
Y 
FMW 
COVER, MATTRESS (MEDICAL PURPOSES) 
HO 
1 
Y 
FNJ 
BED, MANUAL 
HO 
1 
Y 
FNN 
NIPPLE, LAMBS FEEDING 
HO 
1 
Y 
FNP 
URINAL 
HO 
1 
Y 
FNS 
RING CUTTER 
HO 
1 
Y 
FNY 
BASIN, EMESIS 
HO 
1 
Y 
FOA 
BOARD, CARDIOPULMONARY 
HO 
1 
Y 
FOB 
BEDPAN 
HO 
1 
Y 
FOK 
PAD, NEONATAL EYE 
HO 
1 
Y 
FPF 
BOTTLE, HOT/COLD WATER 
1 
Y 
FPP