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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device filter, conduction, anesthetic
Regulation Description Anesthesia conduction filter.
Product CodeBSN
Regulation Number 868.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1
2019 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 3 3
Defective Component 1 1
Detachment of Device or Device Component 1 1
Incomplete or Inadequate Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1 1
No Consequences Or Impact To Patient 1 1
Inadequate Pain Relief 1 1
No Known Impact Or Consequence To Patient 1 1

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