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    K Number
    K140634
    Device Name
    extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit
    Manufacturer
    Devon Medical, Inc.
    Date Cleared
    2014-09-19

    (191 days)

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

    Devon Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The extriCARE® NPWT foam kit is intended to be used in conjunction with the extriCARE® 2400 NPWT pump. The extriCARE® 2400 Negative Pressure Wound Therapy System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed. The extriCARE Negative Pressure Wound Therapy System is indicated for the following wound types: chronic. acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
    Device Description
    The extriCARE® Negative Pressure Wound Therapy (NPWT) System consists of extriCARE® NPWT Pump, canister, connection tubing, and dressing kit. In operation, the dressing is attached to an extriCARE® Negative Pressure Wound Therapy pump via the tubing. The pump is used to provide the negative pressure to the system. Pressure and mode selections are digitally programmable. The extriCARE NPWT foam dressing kit is a new accessory to the NPWT system. The foam dressing kit is designed to be an alternative solution to the bandage dressing kit in the original system. The foam dressing kit consists one of each of the following: polyurethane foam, transparent film drape, paper ruler, Suction Bell with connecting (drainage) tube and clamp. The single-use foam dressing kit is packed in Paper/poly peel pouch bag, which is sterilized using ETO. The foam is used to pack the wound. The extriCARE® NPWT foam dressing kit can be sold alone or as a part of the extriCARE 2400 system. The associated accessories include: - . Large foam dressing kit - . Medium foam dressing kit - . Small foam dressing kit
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