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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name container system for the processing and storage of red blood cell components under reduced oxygen conditions
De Novo Number BR220665
Device Name Hemanext ONE
Product CodeQYC
Device ClassII
Regulation Number864.9115
Submission Type Direct De Novo
Requestor
Hemanext, Inc.
99 hayden ave
bldg b, suite 620
lexington,  MA  02421
Date Received01/05/2022
Decision Date 09/15/2023
DecisionGranted - Direct De Novo
Expedited Review No
Third Party Review Not Third Party Elligble
In Vitro Device? No
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