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510(k) Data Aggregation

    K Number
    K961067
    Device Name
    BURN-AID HYDROGEL,BURN DRESSING,BURN BLANKET
    Manufacturer
    MEDTRAK INTL., INC.
    Date Cleared
    1996-05-16

    (59 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRAK INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BURN-AID Hydrogel, Burn Dressing and Burn Blanket are indicated for single use as a pre-medical first aid for first- and second-degree burns and scalds to cool, soothe and moisturize the burn area.
    Device Description
    BURN-AID Hydrogel is a water-based gel containing extract of Melaleuca alternifolia (tea tree oil) and various stabilizers, emulsifiers and preservatives. The tea tree oil acts as an antiseptic. This gel is available in single-use packets for direct application to the skin. The BURN-AID Burn Dressing is composed of a soft foam sheet impregnated with the BURN-AID Hydrogel. The BURN-AID Burn Blanket is composed of pure virgin wool saturated with the BURN-AID Hydrogel.
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    K Number
    K954506
    Device Name
    EMOX
    Manufacturer
    MEDTRAK INTL., INC.
    Date Cleared
    1996-04-30

    (215 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRAK INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The emOx™ device by MedTrak is intended to generate 99% pure oxygen for emergency first aid administration.
    Device Description
    The emOx™ device is a lightweight, portable device that produces oxygen of greater than 99% purity by a chemical reaction. The evolved oxygen bubbles pass through a water-filled chamber to humidify the gas on its way to the patient via flexible, ribbed tubing and an open adult or pediatric face mask. The device, other than the face mask, does not come into contact with the patient. The mask is a currently legally marketed adult or pediatric mask. The oxygen container is constructed of polypropylene. Therefore, the biocompatibility of the materials used is without significance.
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