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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device peripheral intravenous (piv) infiltration monitor
Definition Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations.
Product CodePMS
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
IVWATCH, LLC
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Sparking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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