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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device set, transfer (blood/plasma)
Regulation Description Transfer set.
Product CodeKSB
Regulation Number 864.9875
Device Class 2


Premarket Reviews
ManufacturerDecision
CHARTER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CHARTER MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
KAWASUMI LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Mechanical Problem 26
Dent in Material 5
Separation Failure 5
Adverse Event Without Identified Device or Use Problem 3
Inadequate User Interface 1
No Apparent Adverse Event 1
Total Device Problems 41


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