Cord Blood Processing System And Storage Container
The Cord Blood Processing System and Storage Container (product code OAO) is a functionally closed system used by cord blood establishments for the processing and cryopreservation of cord blood products, including containers, soft goods, centrifugation systems for cord blood concentration, and a final container for cryogenic storage. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 864.9900 within the Hematology specialty. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OAO
- Device Class
- FDA class 2
- Regulation Number
- 864.9900
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.