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FDA product code QJZ

Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure

CardiovascularClass 221 CFR 870.4100Life-sustaining
Verified
US regulatory classifications
US Product Code (FDA)
QJZ
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.4100
View CFR Regulation
Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
Yes
Third party review
Not Eligible
Definition

Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.

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01Extracorporeal system02ECMO system03Respiratory support04Cardiopulmonary support05Life support06Lung support07Heart support08Critical care09Perfusion system10Temporary support
About this record

Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes life-sustaining products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.