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    K Number
    K972404
    Device Name
    VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)
    Manufacturer
    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
    Date Cleared
    1997-07-22

    (26 days)

    Product Code
    KJA
    Regulation Number
    864.2240
    Why did this record match?
    Product Code :

    KJA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VACUTAINER® Brand Safety Blood Collection Assembly is intended to provide a pre-assembled Direct Draw Adapter/safety needle combination for venipuncture to obtain blood samples. The VACUTAINER® Brand Safety Blood Collection Assembly contains a sliding shield that covers the needle point after use. In the activated position the needle cover guards against accidental needlesticks during normal handling and disposal.
    Device Description
    The VACUTAINER® Brand Safety Blood Collection Assembly is a configuration of the commercially available BDD SafetyGlide™ Needle preattached to a VACUTAINER® Direct Draw Adapter (Blood Collection Holder assembly). The VACUTAINER® Brand Safety Blood Collection Assembly is intended to be marketed as a sterile, multi-sample, single use device.
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