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510(k) Data Aggregation

    K Number
    K051009
    Device Name
    HUBER CLEAR SAFETY INFUSION SET
    Date Cleared
    2005-07-12

    (82 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOW MEDICAL DISTRIBUTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NOW Huber Clear™ Safety Infusion Set is a safety IV administration set with a non-coring, ninety-degree, right-angle Huber needle, used to access surgically implanted vascular ports. The Huber needle is used to administer fluids or to withdraw blood. The Huber Clear™ system facilitates safe removal of the needle by encapsulating the needle within the attachment wings to help prevent needlestick injuries when using the device for vascular port access.
    Device Description
    The NOW Huber Clear™ Safety Infusion Set is a standard non-coring right angle Huber needle and administration set with a needlestick prevention feature. The Huber Clear™ Safety Infusion Set is designed for use with a vascular access infusion system. The NOW Huber Clear™ Safety Infusion Set is fabricated from biocompatible, medical grade materials. The needle is inserted into the vascular access port in a standard manner for fluid infusion or for blood sampling. Removal of the needle is done as with any standard Huber needle, using a one-handed (dominant hand) technique to pull out the needle, and stabilizing the port with the nondominant hand. As the needle is removed, the passive needlestick prevention feature actuates automatically when the users hands are positioned correctly and can be easily seen, felt, and heard by the user to ensure that the needle cover is secure. The NOW Huber Clear™ Safety Infusion Set is supplied sterile and nonpyrogenic, for single use only.
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