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510(k) Data Aggregation

    K Number
    K122297
    Device Name
    ENLUXTRA HUMIFIBER WOUND DRESSING
    Date Cleared
    2012-08-28

    (28 days)

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

    BASF VENTURE CAPITAL AMERICA INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Enluxtra Humifiber™ Wound Dressings are intended as an effective barrier to reduce microbial penetration through the dressing. The Enluxtra Humifiber™ Wound Dressings are for use under healthcare professional's orders for the management of exuding wounds, partial and full thickness wounds, such as pressure ulcers (Stages II-IV), lower extremity ulcers (venous or arterial), diabetic foot ulcers, surgical or traumatic wounds.
    Device Description
    Enluxtra™ Humifiber™ Wound Dressings are soft non-woven fiber based wound care devices that are designed for use on exuding wounds and as effective barriers to reduce microbial penetration through the dressing. Enluxtra™ Humifiber™ Wound Dressings are made of synthetic polymers, consisting of a hydrophilic gelling fiber core enclosed between a wound contact fiber layer and backing film. When the dressing is in contact with breached skin/wound and absorbs wound exudate, the polymer fibers form a gel. The backing film supports the gel and allows for simple one-piece removal of the dressing from the wound. The film prevents fluid strike-through and serves as a microbial barrier to reduce microbial penetration through the dressing. The Enluxtra™ Humifiber™ Wound Dressings are provided as sterile, single use, disposable devices and will be available in a variety of sizes.
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