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510(k) Data Aggregation

    K Number
    K240624
    Device Name
    InfuLife
    Manufacturer
    First Medical Source, LLC
    Date Cleared
    2024-11-05

    (245 days)

    Product Code
    MEB
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    First Medical Source, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InfuLife is a single-use, sterile, disposable elastomeric infusion pump intended for intermittent infusion of medications for general infusion at home, in a hospital, or in alternate sites. InfuLife is indicated for delivery of antibiotics, chemotherapy, and pain management, as directed by a physician or licensed healthcare professional. Routes of administration include intravenous, intra-arterial, subcutaneous, and epidural. Additionally, InfuLife is indicated for continuous and/or intermittent delivery of medication, such as local anesthetics or narcotics, to surgical wound sites and/or proximity to nerves for preoperative, and postoperative regional anesthesia and pain management. InfuLife is intended for use by physicians, clinicians, pharmacists, and other licensed healthcare professionals.
    Device Description
    InfuLife is a non-electrically driven, portable fixed flow rate infusion pump. The fluid is pushed forward by the pressure of the elastomeric bladder. The flow rate of the device is predetermined by the manufacturer using Hagen-Poiseuille theory, which calculates the volumetric flow rate of a fluid with certain viscosity passing through a cylindrical pipe with a known diameter, at a given pressure and temperature.
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