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510(k) Data Aggregation

    K Number
    K072603
    Device Name
    ABC SYRINGE INFUSION PUMP, MODEL 4100
    Manufacturer
    Date Cleared
    2008-10-23

    (405 days)

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

    ELIXIR CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    In any area such as neonatal and pediatric intensive care, anesthesia, adult critical care or any other area where the pump use can be monitored or supervised by a trained healthcare professional where the precise administration of fluids including drugs, antibiotics, lipids, blood, blood products, enteral solutions, or other therapeutic solutions is required. Delivery routes include: Intravenous, arterial, epidural, spinal, enteral, and subcutaneous. Delivery modes include: Continuous, volume/time, mass, body weight, and bolus.
    Device Description
    The ABC Syringe Infusion Pump Model 4100 is software driven and microprocessor controlled electromechanical system, powered by 120VAC converted to DC (or an internal DC battery pack if AC power is not supplied), which is designed to allow the operator to program the infusion of fluid through a syringe and an administration set. The pump delivers fluid by controlling the displacement of the syringe plunger in accordance with the program entered by the operator.
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