OOF

Cryogenic Cord Blood Storage Container

Product code: OOF
Device name: Cryogenic Cord Blood Storage Container
Device class: Class 2
21 CFR: 21 CFR 864.9900
Medical specialty: Hematology
Marketing pathway: 510(K)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OOF

Classification and pathway per current FDA publications. Data from openFDA (CC0).