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510(k) Data Aggregation

    K Number
    K020077
    Device Name
    MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX
    Manufacturer
    AUGUSTINE MEDICAL, INC.
    Date Cleared
    2002-01-31

    (22 days)

    Product Code
    MSA
    Regulation Number
    878.4020
    Why did this record match?
    Product Code :

    MSA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Augustine Medical Wound Care System is intended for the local management of wounds by maintaining moisture and body temperature in the wound bed. It is indicated for partial- and full-thickness wounds, such as venous, arterial and diabetic ulcers, and Stage II through Stage IV pressure ulcers.
    Device Description
    The Augustine Medical wound cover is part of the Wound Care System, which includes a power supply/battery charger, temperature control unit, warming card, and a clean dressing called a wound cover that supports the warming card and holds it away from the wound and skin. The wound cover is a disposable, single-patient-use wound dressing. It is comprised of a thin shell, a window, and a foam frame. The shell has an adhesive border to hold the wound cover in place. It is water-resistant and can be easily cleaned. A clear window in the center of the wound cover allows the caregiver to view and assess the wound, and a pocket on top of the window holds the warming card used during warming therapy. The foam frame absorbs wound fluid (exudate), and keeps the pocket above the wound surface so neither the window nor the warming card contact the wound.
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    K Number
    K963293
    Device Name
    AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX
    Manufacturer
    AUGUSTINE MEDICAL, INC.
    Date Cleared
    1997-03-28

    (219 days)

    Product Code
    MSA
    Regulation Number
    878.4020
    Why did this record match?
    Product Code :

    MSA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Augustine Medical Wound Care System is intended to be used for the local management of wounds by maintaining moisture and body temperature in the wound bed and is indicated for partial and full thickness wounds, such as, Stage I through IV venous, arterial, diabetic, and pressure ulcers.
    Device Description
    The wound care system is comprised of a power supply/battery charger, heater control unit, heater card, and a sterile dressing/bandage called a Wound Cover which supports the heater card and holds it away from the wound and skin. The Wound Cover is a disposable, single-use, sterile, non wound-contact dressing. The Wound Cover may be used either as a stand-alone wound dressing or as part of the Augustine Medical Wound Care System. The Wound Cover incorporates a clear or opaque window. The clear window allows the caregiver to view and assess the tissue. The Wound Cover surrounds and protects the wound, absorbs wound exudate and allows active warming of the periwound area by the application of radiant heat. The warming components of the system include a thin heater card, a control unit, and a power supply/battery charger. The system operates on standard wall outlet electricity or the self-contained batteries. The heater card is sized appropriately to the Wound Cover and attaches easily over the clear window of the Wound Cover. The heater card does not contact the wound and is intended for single patient use. The control unit incorporates temperature safety limits.
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