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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device warmer, blood, non-electromagnetic radiation
Regulation Description Blood and plasma warming device.
Product CodeBSB
Regulation Number 864.9205
Device Class 2


Premarket Reviews
ManufacturerDecision
AUGUSTINE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BELMONT INSTRUMENT CORP.
  SUBSTANTIALLY EQUIVALENT 5
ELLTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LEVEL 1
  SUBSTANTIALLY EQUIVALENT 2
STIHLER ELECTRONIC GMBH
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Information 32
System fails to activate 11
Alarm, audible 5
Heat, failure to 3
No Known Device Problem 3
Fluid leak 2
Use of Device Issue 2
Unknown (for use when the device problem is not known) 2
Infusion or flow issue 1
Insufficient flow or underinfusion 1
Not Applicable 1
Installation error 1
Probe failure 1
Material rupture 1
Alarm, error of warning 1
Accessory incompatible 1
Air leak 1
Total Device Problems 69

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