OAO
- Product code
- OAO
- Device name
- Cord Blood Processing System And Storage Container
- Device class
- Class 2
- 21 CFR
- 21 CFR 864.9900
- Medical specialty
- Hematology
- Marketing pathway
- 510(K)
FDA classification 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.
Official FDA classification page: OAO
Classification and pathway per current FDA publications. Data from openFDA (CC0).