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510(k) Data Aggregation

    K Number
    K131708
    Device Name
    BWCSH-1 SHARPS CONTAINER
    Manufacturer
    BRADFORD WRIGHT COMPANIES, INC
    Date Cleared
    2014-03-10

    (272 days)

    Product Code
    MMK
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRADFORD WRIGHT COMPANIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BWCSH-1 sharps container has a one-gallon fill line capacity that is intended to be used for the safe disposal of hazardous sharps. The BWCSH-1 sharps container is metallic canister fitted with thermal plastic top and has a orange-red biohazard label adhered to the containers with fill line printed on the front. The BWCSH-1 device is for single use, disposable and is not a secondary container. The BWCSH-1 sharps container dimensions are 10.5 inches in width at the top, 4.75 inches deep and 8.25 inches in height. BWCSH-1 sharps container weighs 1.075 pounds when empty.
    Device Description
    The BWCSH-1 sharps container has a one-gallon fill line capacity that is intended to be used for the safe disposal of hazardous sharps. The BWCSH-1 sharps container is stable, puncture resistant, impact and shatter resistant, and leak-proof on the sides and bottom. The BWCSH-1 container is fitted with a rotating top, allowing safe one-handed disposal of used sharps. The container has a locking tamper resistant plastic lid that once snapped in place, cannot be manually removed. Labels are orange-red with black text and a black biohazard symbol printed on a white background. Labels are adhered to the containers at the time of manufacture with the fill line printed. The BWCSH-1 device is for single use, disposable and is not a secondary container. The BWCSH-1 sharps container three main components are nested together to reduce storage and shipping requirements. The rotating top is made with uncolored translucent material. The translucent nature of the product allows for a visual determination of content level. The bottom of the rotating top's internal chute matches the fill line to physically prevent over filling.
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