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510(k) Data Aggregation

    K Number
    K121407
    Device Name
    OXYBAND WOUND DRESSING
    Manufacturer
    Date Cleared
    2012-07-09

    (60 days)

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

    O2S, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    O2S OxyBand™ Wound Dressings assist in managing wound healing. O2S OxyBand™ Wound Dressings can be used to protect light to moderate wounds including skin tears, scrapes, minor pressure sores, abrasions, blisters, lacerations, and minor burns, chafed or irritated skin. OxyBand™ Wound Dressings are intended to provide a moist, oxygen rich environment to facilitate the normal wound healing process. OxyBand™ Wound Dressings can be used to cover and protect wounds and cather sites, or used as a secondary dressing for other wound products such as gauze, alginates, hydrogels, debritement facilitators, or a protective cover over at risk skin. Common applications include: clean dosed surgical incisions, sin graft donor sites, Slage I or II pressure ulcers, pressure sores, superficial wounds such as abrasigns, skirtes, and blisters, lacerations, first and second degree burns, chafed skin, skin continuously exposed to moisture, secondary dressing over gauze, alginates or hydrogels.
    Device Description
    The OxyBand™ Wound Dressing is made up of a thin polyurethane film commonly used in other wound dressings, with adhesive that seals around the wound at the perimeter of the dressing. An occlusive oxygen barrier film is sealed over the polyurethane film to hold a layer of oxygen over the high oxygen permeability polyurethan
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