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510(k) Data Aggregation
K Number
K083355Device Name
WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553
Manufacturer
BLAIREX LABORATORIES, INC.
Date Cleared
2008-12-29
(46 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BLAIREX LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Wound Wash Saline® is intended to be used for cleansing dermal wounds. The label declared indications are: " To cleanse wounds, scrapes and minor burns." The mechanical action of sterile isotonic saline solution irrigating the wound provides for the removal of foreign material such as, but not exclusively, dirt and debris. Wound Wash Saline® can be used to remove tissue debris, wound exudate, and other extraneous matter. Bacteria and tissue metabolic products may also be removed or reduced in level allowing for the natural healing process to take place unimpeded. It may also be used to moisten wound dressings to ease removal from the wound area.
Wound Wash Saline® is indicated for use in cleansing wounds, scrapes, and minor burns
Device Description
Wound Wash Saline® is a multi-use, isotonic sterile saline solution packaged in a bag-incan 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 to15 psi [Clinical Practice Guideline Number 15, AHCPR, U.S. 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 exudate 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]. Wound Wash Saline® passes the USP<71> Sterility Test. Wound Wash Saline® is an OTC device and will only be labeled for use in cleansing wounds, including the removal of foreign material such as dirt and debris.
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