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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device oxygenator, long term support greater than 6 hours
Regulation Description Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
Product CodeBYS
Regulation Number 870.4100
Device Class 2


Premarket Reviews
ManufacturerDecision
MC3 INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 3 3
Partial Blockage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 2 2

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