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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device container system for the processing and storage of red blood cell components under reduced oxygen conditions
Regulation Description Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions.
Definition The container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions is a device intended for medical purposes that is used to process and store Red Blood Cell components and reduce oxygen levels in the storage environment.
Product CodeQYC
Regulation Number 864.9115
Device Class 2


Premarket Reviews
ManufacturerDecision
HEMANEXT INC.
  SUBSTANTIALLY EQUIVALENT 1

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