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U.S. Department of Health and Human Services

Product Classification

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Device plasma thawer
Regulation Description Blood and plasma warming device.
Definition For thawing frozen plasma prior to transfusion.
Physical State various shapes, may be composed of metal and plastic
Technical Method Electromagnetic
Target Area Frozen plasma
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodePGG
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.9205
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible