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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device cap, device disinfectant
Definition Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time
Product CodeQBP
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
STAR MOUNTAIN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3 3
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Gas Leak 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1 1
No Consequences Or Impact To Patient 1 1
No Known Impact Or Consequence To Patient 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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