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510(k) Data Aggregation

    K Number
    K061919
    Device Name
    VERSATILE 1 EZCARE WOUND VACUUM SYSTEM
    Manufacturer
    BLUE SKY MEDICAL GROUP INCORPORATED
    Date Cleared
    2007-02-05

    (214 days)

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

    BLUE SKY MEDICAL GROUP INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Versatile 1 EZCare™ Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.
    Device Description
    The product is a portable suction pump that may promote wound healing when used with accessory wound sealing kits.
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    K Number
    K061367
    Device Name
    BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500
    Manufacturer
    BLUE SKY MEDICAL GROUP INCORPORATED
    Date Cleared
    2006-08-10

    (86 days)

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

    BLUE SKY MEDICAL GROUP INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BlueSky VISTA™ Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.
    Device Description
    The product is a portable suction pump that may promote wound healing when used with accessory wound sealing kits.
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    K Number
    K052456
    Device Name
    MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM
    Manufacturer
    BLUE SKY MEDICAL GROUP INCORPORATED
    Date Cleared
    2005-11-04

    (58 days)

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

    BLUE SKY MEDICAL GROUP INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Versatile 1 Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from a patients airway or respiratory support system either during surgery or at the patients bedside.
    Device Description
    The product is a portable suction pump for general purpose drainage or for the promotion of wound healing when used with various accessory wound sealing kits.
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    K Number
    K042134
    Device Name
    VERSATILE 1 WOUND VACUUM SYSTEM
    Manufacturer
    BLUE SKY MEDICAL GROUP INCORPORATED
    Date Cleared
    2004-11-01

    (84 days)

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

    BLUE SKY MEDICAL GROUP INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Versatile 1 Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids, or infectious materials from a patients airway or respiratory support system either during surgery or at the patients bedside.
    Device Description
    The BlueSky Versatile 1 WVS is a portable suction device that can be powered by an internal battery pack, wall current or 12 Volt input via optional cigarette lighter adaptor. The pump can be used for removal of surgical fluids, tissue, gases, bodily fluids or infected materials during surgery or from a patients airway or respiratory support system. The pump can also be used to create localized topical negative pressure when used with the Chariker-Jeter® accessory kits to promote wound healing and drainage of fluids and infected materials from the wound into a disposable or reusable canister. The BlueSky versatile 1 Wound Vacuum System (V1 WVS) consists of a medium sized housing that contains a vacuum pump and control system with a location for a fluid canister system. Accessories include are a vehicle power adaptor and a Mobil Stand. A variety of disposables are available from a number of medical device manufacturers depending on the pump application. For the expanded indication of use for wound healing the Chariker -Jeter® accessory kits would be available from BlueSky Medical. This kit consists of individually reviewed medical components that have added instructions for use. The Versatile 1 Wound Vacuum system is an ideal pump for military use and triage use. By combining a unit that can be used for wound resolution as well as tracheal use or for use in the operating theatre a minimum of products can be used for maximum versatility. The BlueSky V1 WVS is 15 inches by 11.2 inches by 6.7 inches and weighs 11.2 pounds. The battery will last for 30-45 minutes when not plugged in. the Pump can additionally be powered by a 12 volt source such as a cigarette lighter adaptor. Switching the power switch to either continuous or intermittent suction turns on the pump. Pressing inwards on the suction control knob and then turning the knob in the desired direction adjust the level of suction. The knob will lock when it is not pressed to avoid accidental changes. The operator will view the suction gauge and when proper suction is reached the knob can be released. Canisters The pump includes a 250ml reusable polysulfone canister that can be autoclaved. The canister includes a mechanical overflow float to prevent backups into the pump itself. The canister can be autoclaved in a standard hospital autoclave for 134 degrees Celsius for 10 minutes. The pump also includes a 800ml liter disposable canister that has a mechanical overflow float. This canister is non-sterile and is designed by be discarded when full or partially full. Single Use Disposables Marketed as part of the VI Wound Vacuum System is a disposable kit. This kit is named after the pioneers in the field Katherine Jeter and Dr. Mark Chariker who popularized this technique of wound drainage, which caused wounds to heal more rapidly. "From the days of drainage through ostomy pouches to the current use of suction systems there has evolved a closed suction system incorporating moist wound management principals with the benefits of an inert silicone drain to maximize wound healing" " The Chariker-Jeter wound vacuum system accessory kit. These kits consist of products from existing manufacturers that have met the regulatory requirements of the FDA. They include an additional set of instructions for use. The Kits include: 1. Silicone or Wound drain 2. Connecting tubing 3. Impregnated gauze 4. Gauze fill Material 5. Polyurethane Cover dressing
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