OOF — Cryogenic Cord Blood Storage Container Class II
FDA product code OOF covers "Cryogenic Cord Blood Storage Container", a Class II medical device regulated under 21 CFR 864.9900. Submissions are reviewed by the Hematology panel.
Classification Details
- Product Code
- OOF
- Device Class
- Class II
- Regulation Number
- 864.9900
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
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.