FDA product code OAO: Cord Blood Processing System And Storage Container
OAO is the FDA product code for cord blood processing system and storage container. It is a Class II device, regulated under 21 CFR 864.9900 and reviewed by the Hematology panel. Devices under OAO reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Cord Blood Processing System And Storage Container |
| Device class | Class II |
| Regulation | 21 CFR 864.9900 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Recalls for OAO devices
openFDA lists no recalls for product code OAO.
Frequently asked questions
What is FDA product code OAO?
OAO is the FDA product code for cord blood processing system and storage container. It is a Class II device, regulated under 21 CFR 864.9900 and reviewed by the Hematology panel.
What device class is OAO?
Class II, regulation 21 CFR 864.9900. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OAO
- Run a recall and safety report across every OAO manufacturer
- Watch product code OAO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.