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510(k) Data Aggregation

    K Number
    K023690
    Device Name
    CATHETER CONNECTOR
    Manufacturer
    Date Cleared
    2003-02-28

    (119 days)

    Product Code
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    WORLD METALS, INC,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Quick Disconnect Plug is Intended to stop the flow of urine from the urinary catheter to the drainage bag. It is intended for use on a short term basis of no longer than two weeks (14 days) duration. The dally disconnection schedule should not exceed two hours. This device is available sterile for one-time use by physician's prescription.
    Device Description
    The Quick Disconnect Plug is designed to facilitate a speedy, comfortable, and safe rehabilitation for patients requiring use of a urinary catheter. The use of a urinary catheter to facilitate drainage from the bladder is usual and customary following most surgery. In using a catheter, it is connected to a collection bag, which becomes a potential physical hazard and a source of discomfort to the patient in attempting to do rehabilitative exercise. The Quick Disconnect Plug allows the patient and/or attending nurse or physician to quickly disconnect the catheter from the drainage bag, leaving one half of the Quick Disconnect Device, which has a shut-off valve built in, in the open end of the catheter and seals off the flow of urine until such time as it is reconnected and the flow is once again resumed between the catheter and the collection bag.
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