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510(k) Data Aggregation

    K Number
    K123194
    Device Name
    JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088
    Manufacturer
    NORTH AMERICAN RESCUE PRODUCTS, INC.
    Date Cleared
    2013-01-03

    (84 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTH AMERICAN RESCUE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The North American Rescue Junctional Emergency Treatment Tool is indicated for emergent purposes to control difficult bleeds in the inguinal area.
    Device Description
    The Junctional Emergency Treatment Tool is designed to be used by first responders for emergent purposes. The device is designed to control bleeding in the inguinal area where standard tourniquets cannot be used. The device can be used instead of manual pressure, allowing the healthcare provider to attend to other casualties. The Junctional Emergency Treatment Tool is used to control a difficult bilateral or unilateral bleeding for up to 4 hours until the casualty can be transferred for treatment. The Junctional Emergency Treatment Tool consists of a belt assembly, with two trapezoidal pressure pads and Threaded T-Handles. The two pressure pads allow the provider to treat a casualty with either unilateral or bilateral injuries.
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