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510(k) Data Aggregation

    K Number
    K133333
    Device Name
    UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT
    Manufacturer
    BLUE OCEAN MEDICAL PRODUCT, LLC.
    Date Cleared
    2014-12-31

    (428 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    BLUE OCEAN MEDICAL PRODUCT, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UNI NPWT Foam Dressing Kit is intended to be used in conjunction with the Simex Negative Pressure Wound Therapy Pumps (K113291) for the application of negative pressure wound therapy to the wound. When used in conjunction with the Simex Negative Pressure Wound Therapy Pumps, the UNI NPWT Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris. The UNI NPWT Foam Dressing Kit is appropriate for use on the following wounds: - Pressure Ulcers - Diabetic/Neuropathic Ulcers - Venous Insufficiency Ulcers - Traumatic Wounds - Post-Operative and Dehisced Surgical Wounds - Skin Flap and Grafts
    Device Description
    The UNI NPWT Foam Dressing Kit without pump is manufactured using a reticulated flexible polyether based polyurethane hydrophobic foam material. The UNI NPWT Foam Dressing Kit includes the (1) foam dressing, (2) occlusive drape and (3) silicon suction dome with (4) negative pressure tubing. UNI NPWT Foam Dressing Kit is available in three sizes; 1) small, 2) medium and 3) large.
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