Product code OOF

Device name

Cryogenic Cord Blood Storage Container

Medical specialty

Hematology

Device class

2

Regulation number

864.9900

Review panel

HE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset