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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cord blood processing system and storage container
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.
Product CodeOAO
Regulation Number 864.9900
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOSAFE SA
  SUBSTANTIALLY EQUIVALENT 3
CRYO-CELL INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SYNGEN, INC
  SUBSTANTIALLY EQUIVALENT 1
THERMOGENESIS CORP
  SUBSTANTIALLY EQUIVALENT 1

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