OAO — Cord Blood Processing System And Storage Container Class II
FDA product code OAO covers "Cord Blood Processing System And Storage Container", a Class II medical device regulated under 21 CFR 864.9900. Submissions are reviewed by the Hematology panel.
Classification Details
- Product Code
- OAO
- Device Class
- Class II
- Regulation Number
- 864.9900
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Definition
A cord blood processing system and storage container is a device intended for use in the processing and the storage of cord blood. This device is used as a functionally closed processing system by cord blood establishments. This device includes containers, other soft goods, and centrifugation systems for cord blood product concentration, and a final container for the cryopreservation and the storage of cord blood products.