FDA product code OOF

Cryogenic Cord Blood Storage Container

Hematology·Class 2·21 CFR 864.9900
US regulatory classifications
US Product Code (FDA)
OOF
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 864.9900
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Medical specialty
Hematology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Intended as a final container for the cryopreservation and the storage of cord blood products. A cryogenic cord blood storage container is a flexible ethylene vinyl acetate (eva) or similar polymer bag intended as a final container for cryopreservation and storage of cord blood products in the liquid or vapor phases of liquid nitrogen.

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About this record

Cryogenic Cord Blood Storage Container is a medical device type in the Hematology 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.