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OAOClass II

Cord Blood Processing System And Storage Container

21 CFR 864.9900 / Hematology
FDA source (opens on fda.gov)

OAO is the FDA product code for Cord Blood Processing System And Storage Container, a class II device type, regulated under 21 CFR 864.9900. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OAO
Device name
Cord Blood Processing System And Storage Container
FDA 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.
Regulation
21 CFR 864.9900
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code