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510(k) Data Aggregation

    K Number
    K213955
    Device Name
    0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub
    Manufacturer
    Becton, Dickinson and Company
    Date Cleared
    2022-07-16

    (211 days)

    Product Code
    QTI, OTI
    Regulation Number
    880.5200
    Why did this record match?
    Product Code :

    QTI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SafeScrub prefilled flush syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs.
    Device Description
    BD PosiFlush™ SafeScrub is a sterile, single use pre-filled saline syringe with integrated Disinfection Unit (DU). The polypropylene syringe contains 0.9% sodium chloride (USP) solution with a tip cap that is modified at the distal end to accommodate DU. The DU has high density polyethylene housing with 70% Isopropyl Alcohol (IPA) solution in low density polyethylene foam. The pre-filled syringe with modified syringe tip cap is sterilized by moist heat and the DU is sterilized by gamma irradiation. The subject device is available only in 10mL syringe configuration.
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