Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K972469
    Device Name
    SELFSHIELD HN SELF SHEATHING HYPODERMIC NEEDLE
    Manufacturer
    BEECH MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-08-27

    (57 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEECH MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SELFSHIELD HN™ Self Sheathing Hypodermic Needle is indicated for non patient contacting and non-skin penetrating applications such as fluid transfer from a drug vial or ampoule to an IV administration set injection site (Y-site) or an IV catheter intermittent injection cap (heparin lock).
    Device Description
    The SelfShield HN™ device incorporates a standard hypodermic needle which adapts to piston syringe standard luer fittings. The device embodies a spring loaded needle shield which automatically covers the needle tip prior to and after each use. It helps reduce the occurrence of accidental needlesticks to healthcare workers when the product is used as directed. The user activates the device by placing the tip of the shield against a rubber injection site, clockwise rotating the device by at least 40° and pushing the shield back until the needle tip penetrates into and beyond the injection site rubber plug. Once fluid, drug, agent or blood is drawn, the unit is removed from the injection site. The needle shield automatically advances covering and protecting the sharp tip for transport. The device is reactivated again against another injection site until disposed in an approved sharps container. The device is supplied sterile in a peelable Tyvek-nylon blister package.
    Ask a Question

    Page 1 of 1