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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cryogenic cord blood storage container
Regulation Description Cord blood processing system and storage container.
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.
Product CodeOOF
Regulation Number 864.9900
Device Class 2