FDA product code QIK

Organ Care System (Ocs) Heart System

Unknown·Class 3·21 CFR ·Life-sustaining
US regulatory classifications
US Product Code (FDA)
QIK
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US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR
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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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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.