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U.S. Department of Health and Human Services

Product Classification
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Product
Code
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Device
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Regulation
Number
sort by regulation number [0-9]
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Device
Class
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BSD
analyzer, gas, nitrogen, partial pressure, blood-phase, non-indwelling  
3
LSZ
ventilator, high frequency  
3
MNQ
stimulator, hypoglossal nerve, implanted, apnea  
3
NJK
valve, pulmonary  
3
OAZ
one-way air-leak valve  
HDE
OIR
diaphragmatic/phrenic nerve laparoscopically-implanted stimulator  
3
OOY
bronchial thermoplasty system  
3
PDR
computer-assisted personalized sedation system  
3
PNC
catheter introducer  
not classified
POI
lung tissue sealant for lung volume reduction  
not classified
PSR
implanted phrenic nerve stimulator for central sleep apnea  
3
QGZ
electrical tumor treatment fields  
3
QKS
inhaler, metered dose or dry powder, cder or cber led  
not classified
QLI
vaporizer, cder or cber led  
not classified
QOQ
non-continuous ventilator for emergency use  
not classified
QOR
continuous ventilator, minimal ventilatory support  
not classified
QOT
emergency ventilator  
not classified
QOU
emergency resuscitator  
not classified
QOW
ventilatory assistance helmet  
not classified
QPR
neurological stimulation for emergency use  
not classified
QSF
software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and ane...  
3
QTB
nitric oxide generator and delivery system  
3
SDA
electrical tumor treatment fields for non-small cell lung cancer  
3
SDL
transvenous temporary phrenic nerve stimulator  
3
LHE
controller, closed-loop blood glucose  
3
LKV
enzyme immunoassay, fetal fibronectin  
3
LMY
monitor, skin resistance/skin temperature, for insulin reactions  
3
LTC
hyaline membrane disease assay  
3
MDS
sensor, glucose, invasive  
3
MWQ
system, test, total antioxidant status  
3
NCT
instrument, glucose, noninvasive technology  
3
NQC
test, breath analysis, volatile organic compounds  
HDE
NUK
for export only - antigen, anti-cardiac, indirect fluorescent antibody test system  
not classified
NUL
for export only - antigen, anti-skeletal, indirect fluorescent antibody test system  
not classified
OTV
research use only/clinical chemistry devices  
not classified
OYC
pump, infusion, insulin, to be used with invasive glucose sensor  
3
OZO
automated insulin dosing , threshold suspend  
3
OZP
automated insulin dosing device system, single hormonal control  
3
OZQ
automated insulin dosing device system, bihormonal control  
3
PAQ
test, nr2 antibody  
not classified
PAR
test, volatile organic compounds breath analysis  
HDE
PDA
investigational use only - clinical chemistry  
not classified
PEJ
salivary estriol test  
3
PHK
test, cell mediated immune response, liver and small bowel transplant/transplantation  
not classified
PQF
sensor, glucose, invasive, non-adjunctive  
3
PZE
sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated  
3
QCD
continuous glucose monitor, implanted, adjunctive use  
3
QHJ
sensor, glucose, implanted, non-adjunctive use  
3
SCE
ivd offered as ldt, first marketed before may 6, 2024, not modified beyond scope described in preamb...  
not classified
SCF
ldt, unmet need within an integrated healthcare system  
not classified
SCG
modified version of another manufacturer’s fda-authorized test within scope described in preamble to...  
not classified
SCH
ldt, approved by nys clep  
not classified
SCI
ivd offered as ldt, not an ldt or under a targeted enforcement discretion policy described in preamb...  
not classified
SCJ
ldt, not under a targeted enforcement discretion policy described in preamble to ldt final rule  
not classified
SFI
sensor, glucose, invasive, component of automated insulin delivery system  
3
DSQ
ventricular (assist) bypass  
3
FZC
prosthesis, arterial graft, bovine carotid artery  
3
LIW
fibrillator, ac  
Unclassified
LOT
pulse-generator, program module  
3
LOZ
artificial heart  
3
LPA
system, esophageal pacing  
3
LPB
cardiac ablation percutaneous catheter  
3
LPC
device, angioplasty, laser, coronary  
3
LWO
pulse-generator, single chamber, sensor driven, implantable  
3
LWP
implantable pulse generator, pacemaker (non-crt)  
3
LWQ
heart-valve, mechanical  
3
LWR
heart-valve, non-allograft tissue  
3
LWS
implantable cardioverter defibrillator (non-crt)  
3
LWT
occluder, balloon, vena-cava  
3
LWW
pulse-generator, single chamber, single  
3
LWX
device. laser peripheral angioplasty  
3
LWZ
tissue graft of less than 6mm  
3
LXA
tissue graft of 6mm and greater  
3
MAD
catheter, percutaneous (valvuloplasty)  
3
MAE
occluder, patent ductus, arteriosus  
3
MAF
stent, coronary  
3
MCX
catheter, coronary, atherectomy  
3
MFA
device, removal, pacemaker electrode, percutaneous  
3
MGB
device, hemostasis, vascular  
3
MIE
heart-valve, allograft  
3
MIH
system, endovascular graft, aortic aneurysm treatment  
3
MIR
shunt, portosystemic, endoprosthesis  
3
MLV
transcatheter septal occluder  
3
MNO
system, laser, transmyocardial revascularization  
3
MOM
system, hemodynamic, implantable  
3
MOU
intravascular radiation delivery system  
3
MRM
defibrillator, implantable, dual-chamber  
3
MTE
system, pacing, temporary, acute, internal atrial defibrillation  
3
MUQ
glue, surgical, arteries  
3
MVK
wearable automated external defibrillator  
3
MWG
system, oxygen, aqueous  
3
MWH
pulmonic valved conduit  
HDE
NAP
cardiac support mesh wrap  
not classified
NAV
graft, bypass, coronary artery  
HDE
NGV
system, appendage closure, left atrial  
3
NIK
defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)  
3
NIM
stent, carotid  
3
NIN
stent, renal  
3
NIO
stent, iliac  
3
NIP
stent, superficial femoral artery  
3

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