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FDA product code QIK

Organ Care System (Ocs) Heart System

UnknownClass 321 CFR Life-sustaining
Verified
US regulatory classifications
US Product Code (FDA)
QIK
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
Yes
Third party review
Not Eligible
Definition

A portable ex vivo organ perfusion system used to preserve a donor heart for transplantation into a potential recipient.

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01Organ care02OCS heart03Heart transplant04Organ preservation05Perfusion system06Transport system07Cardiac device08Donor heart09Heart machine10Life support
About this record

Organ Care System (Ocs) Heart System 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. 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.