FDA product code OOF: Cryogenic Cord Blood Storage Container
OOF is the FDA product code for cryogenic cord blood storage container. It is a Class II device, regulated under 21 CFR 864.9900 and reviewed by the Hematology panel. Devices under OOF reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Cryogenic Cord Blood Storage Container |
| Device class | Class II |
| Regulation | 21 CFR 864.9900 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Recalls for OOF devices
openFDA lists no recalls for product code OOF.
Frequently asked questions
What is FDA product code OOF?
OOF is the FDA product code for cryogenic cord blood storage container. It is a Class II device, regulated under 21 CFR 864.9900 and reviewed by the Hematology panel.
What device class is OOF?
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 OOF
- Run a recall and safety report across every OOF manufacturer
- Watch product code OOF 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.