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510(k) Data Aggregation

    K Number
    K200425
    Device Name
    Female Luer Lock Cap
    Date Cleared
    2020-10-29

    (252 days)

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

    MedSafety Solutions LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Female Luer Lock Cap is indicated for use as a cap for male Luer fittings on medical devices such as manifolds, stopcocks or IV sets.
    Device Description
    The Female Luer Lock Cap is an individually packaged, sterile, single use disposable product used to cover male Luer fittings. Luer fittings are commonly used on IV administration products and accessories to provide universal compatibility and are well established in the market. Luer lock fittings are securely joined by means of a tabbed hub on the female fitting which screws into threads in a sleeve on the male fitting. The Female Luer Lock Cap is an injection molded, polyethylene component. Polyethylene material is durable, biologically inert, gamma stable, and used extensively in the medical device industry. The product is terminally gamma sterilized to a Sterility Assurance Level (SAL) of 10-6.
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