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510(k) Data Aggregation

    K Number
    K162159
    Device Name
    VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing
    Manufacturer
    VR Medical Technologies, LLC
    Date Cleared
    2017-04-28

    (269 days)

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

    VR Medical Technologies, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VR Medical VCare 1000-300S Negative Pressure Wound Therapy System is an integrated wound management system, indicated for wound management via the application of negative pressure to the wound, in order for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
    Device Description
    The VR Medical VCare 1000-300S System is an AC-Powered portable suction device, with battery backup, that provides localized negative pressure when used with the VR Medical Perme-Foam Dressing to remove fluid, irrigation solutions and infectious materials from the wound. The systems consist of a powered suction pump device with a built-in placement holder for the disposable fluid collection canister, and a foam dressing kit. The kit consists of polyurethane foam, suction bell with connecting (drainage) tube and clamp, and polyurethane drape. The single-use foam dressing kit is packaged in a PE/PET peel pouch bag, which is gamma sterilized. The Foam Dressing Kit (VR Medical Perme-Foam Dressing) can be sold alone or as a part of the VCare 1000-300S System in two sizes: - Large foam dressing kit - Medium foam dressing kit - The Foam Dressing can be used for up to 72 hours of continuous use.
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