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510(k) Data Aggregation

    K Number
    K190742
    Device Name
    EPIFLO-28
    Date Cleared
    2019-12-13

    (266 days)

    Product Code
    Regulation Number
    878.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Neogenix, LLC dba Ogenix

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EPIFLO-28 is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions, 2) pressure ulcers, 3) amputations/infected stumps, 4) skin grafts, 5) burns, and 6) frostbite.
    Device Description
    EPIFLO-28 is an oxygen delivery device that incorporates a disposable oxygen concentrator. It consists of (1) the oxygen concentrator, and (2) the sterile cannula. The oxygen concentrator is a single patient, single use, disposable, battery-operated device that is capable of delivering 98 to 100 percent oxygen continuously for twenty eight days at a rate of ~3.0 ml/hour. The cannula conveys the oxygen from the oxygen concentrator to the area beneath the bandage overlying the wound.
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