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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
CATHETER CONNECTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 7
CLEANSITE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXCELSIOR MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
ICU MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
IVERA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
IVERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
STAR MOUNTAIN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3 3
2021 1 1
2023 1 1

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Unspecified Infection 1 1
No Consequences Or Impact To Patient 1 1
No Known Impact Or Consequence To Patient 1 1

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