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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
  1.  K093229  CATHETER CONNECTIONS DUALCAP
  2.  K112985  CATHETER CONNECTIONS' DUALCAP DUO
  3.  K113842  CATHETER CONNECTIONS' DUALCAP SOLO
  4.  K123065  CATHETER CONNECTIONS DUALCAP SOLO
  5.  K123967  CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE L ...
  6.  K142399  DualCap IV Pole Strips(Disinfectant Caps for Male ...
  7.  K142806  DualCap
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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