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510(k) Data Aggregation

    K Number
    K090848
    Device Name
    PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM
    Manufacturer
    PREMIER BRANDS OF AMERICA, INC.
    Date Cleared
    2009-06-17

    (79 days)

    Product Code
    FQH, FRO
    Regulation Number
    880.5475
    Why did this record match?
    Applicant Name (Manufacturer) :

    PREMIER BRANDS OF AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for Prescription (Rx) Use: Saline Wound Wash is intended for use by or under the direction of a professional health care provider in moistening and lubricating absorbent wound dressings, cleansing and maintaining a moist wound environment for traumatic wounds such as pressure sores, leg ulcers of diabetic and vascular origin, cuts abrasions and minor burns. Indications for Over the Counter (OTC) Use: Saline Wound Wash is intended for use in moistening and lubricating absorbent wound dressings and for cleansing minor wounds, scrapes and minor burns. If redness, swelling or bleeding continues please seek the help of a nurse, nurses aid, doctor or other medical professional.
    Device Description
    Saline Wound Wash is a multi-use, isotonic, sterile saline solution packaged in a bag-in-can aerosol system. Actuation of the device (product can) delivers a consistent flow of sterile isotonic saline solution at published safe and effective wound impact pressures of 4 to 15 psi (Clinical Practice Guideline Number 15, AHCPR, US Department of Health and Human Services). The mechanical action of isotonic saline solution moving across the wound aids in the removal of foreign material, such as dirt and debris, as well as any necrotic tissue, wound exudates, and other extraneous matter. No preservatives are added since the finished device is sterilized by gamma irradiation under parameters that have been validated according to ISO/AAMI 11137 requirements (Sterilization of health care products - Requirements for validation and routine control - radiation sterilization). Saline Wound Wash passes the USP<71> Sterility Test. Saline Wound Wash is an Rx and OTC device and will only be labeled for use in wounds.
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