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U.S. Department of Health and Human Services

Product Classification
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Device cord blood processing system and storage container
Regulation Description 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.
Physical State x
Technical Method x
Target Area blood storage
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeOAO
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type 510(k)
Regulation Number 864.9900
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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