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FDA product code QBA

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

UnknownClass 321 CFR
Verified
US regulatory classifications
US Product Code (FDA)
QBA
View Product Code Classification
US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR
View CFR Regulation
Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

To preserve donor lungs prior to transplantation

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01lung perfusion02organ preservation03lung preservation04perfusion system05transplant system06donor lung07machine perfusion08normothermic perfusion09lung transplant10organ support
About this record

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation is a medical device type in the Unknown 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.

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.