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U.S. Department of Health and Human Services

Product Classification
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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.
Physical State Assembly of two components the Oxygen Reduction Bag (ORB) and the Storage Bag (HSB)
Technical Method Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions.
Target Area Human clinical specimens
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeQYC
Premarket Review CBER Division (CBER)
Submission Type 510(k)
Regulation Number 864.9115
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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