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U.S. Department of Health and Human Services

Product Classification

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Device red cell thawer, microwave
Regulation Description Blood and plasma warming device.
Definition For thawing red cells prior to transfusion.
Physical State may be of various shape; can be metal or platic or a combination of metal and plastic
Technical Method electromagnetic
Target Area frozen red cells
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodePGF
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type PMA
Regulation Number 864.9205
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible