• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device warmer, blood, electromagnetic radiation
Regulation Description Blood and plasma warming device.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeBSA
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type PMA
Regulation Number 864.9205
Device Class 3
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
-
-