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U.S. Department of Health and Human Services

Product Classification

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Device peripheral intravenous (piv) infiltration monitor
Regulation Description Infusion pump.
Definition Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations.
Physical State The device consists of a monitor, a reusable optical sensor cable and a single-use sensor receptacle.
Technical Method The peripheral intravenous (PIV) monitoring device that uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site to determine if an infiltration of the peripheral catheter has occurred.
Target Area peripherally-inserted IVs (PIVs), generally on the forearm or dorsal aspect of the hand.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodePMS
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.5725
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible