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510(k) Data Aggregation

    K Number
    K172486
    Device Name
    Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle
    Manufacturer
    Anexa Biomedical, Inc.
    Date Cleared
    2017-09-21

    (35 days)

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

    Anexa Biomedical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Over-the-Counter Use: For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. For Prescription Use: For moistening absorbent wound dressings and for moistening, debriding and cleaning acute and chronic dermal lesions, such as stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.
    Device Description
    The Sterile Water and Sterile Normal Saline devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile normal saline for irrigation and meets the requirements of USP<40>. The devices are offered in 100mL, 250mL, and 500mL bottles, and 120mL cups.
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    K Number
    K161658
    Device Name
    Anexa Wound Flush, Sterile Water & Sterile Normal Saline
    Manufacturer
    ANEXA BIOMEDICAL, INC.
    Date Cleared
    2016-09-14

    (90 days)

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

    ANEXA BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For moistening of absorbent wound dressings and irrigation to remove loose debris and dirt from the wound.
    Device Description
    The Wound Flush, Sterile Water & Sterile Normal Saline device can be used 1) for moistening a dry sterile dressing for wound cleansing and 2) irrigation to remove loose debris and dirt from the wound. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of loose foreign material such as dirt and debris. The product has a shelf life of 2-years. The solution is available as sterile saline for irrigation and is gamma sterilized. The subject device is offered in various bottle sizes of 100ml, 250ml, and 500ml and cup sizes of 120ml.
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