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510(k) Data Aggregation

    K Number
    K112874
    Device Name
    EZ VEIN INFLATABLE TOURNIQUET
    Manufacturer
    DOMINION MEDICAL DEVICES, LLC
    Date Cleared
    2011-10-17

    (17 days)

    Product Code
    KCY
    Regulation Number
    878.5910
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOMINION MEDICAL DEVICES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EZvein™ inflatable secondary tourniquet is used in conjunction with a nonpneumatic tourniquet, to enhance the presentation of veins for access (blood draw or IV administration.)
    Device Description
    The EZ Vein inflatable secondary tourniquet is made with soft fabric and flexible plastic to form an inflatable bladder. The integral Velcro attachment strips secure the EZVein around an appendage in the same way as would a blood pressure cuff. Dimensions have been chosen to wrap around most anyone's arm, but an extension is included to allow the EZVein to work on lower limbs or with large arms. The Vein Access Window allows the health care professional to position the EZVein over the target vein for access for IV drip, blood draw or injection. The EZVein cuff is applied after the initial conventional non-inflatable tourniquet (such as latex tubing) is applied. The initial tourniquet, as is conventional, blocks the return of venous blood through the major veins to the heart, but the application of the EZVein inflatable cuff helps move the blood in deep tissues into the veins to help them to distend for easier visualization and access. This may aid the medic desiring venous access to more accurately and rapidly achieve the desired aim.
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