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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device gas control unit, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass gas control unit.
Product CodeDTX
Regulation Number 870.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
SORIN
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 37
Malfunction 11
Device displays error message 6
Device operates differently than expected 3
Improper flow or infusion 2
Incorrect or inadequate result 2
Gas delivery system failure 1
Device Issue 1
Infusion or flow issue 1
Improper gas output 1
Total Device Problems 65

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