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510(k) Data Aggregation

    K Number
    K963987
    Device Name
    CAMOUFLAGE CUFF SAVERS
    Date Cleared
    1997-07-23

    (292 days)

    Product Code
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    N.A. BRAGGS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the Cuff Saver will be to cover all types of blood pressure cuffs and/or cuff bladders prior to the cuff or cuff bladder being applied to the patient. This will protect the patient and the health care worker from overt and covert exposure since blood pressure cuffs are often contaminated.
    Device Description
    The Camouflage Cuff Saver is essentially a non woven paper drape that can cover/contain a reusable blood pressure cuff, a disposable cuff, or a cuff bladder. It is fluid repellent and acts to ensure a clean cuff for each patient as it is discarded after single patient use. It is manufactured of medical grade Sontara non woven fiber with 3M brand double sided adhesive tape as a fastening along one vertical edge of the unit and an adhesive patch located on the printed side of the unit. This patch is used to secure the device to its own surface after the device and the cuff it covers are applied to the patients arm. As stated, the device is printed with a design and typical marking for a blood pressure cuff (Artery placement, Range line, etc.). It is available on a perforated roll so that the user can tear off one unit at a time just as one removes a paper towel from its roll.
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