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510(k) Data Aggregation

    K Number
    K113015
    Device Name
    ALDAHOL V HIGH LEVEL DISINFECTANT
    Date Cleared
    2012-01-30

    (111 days)

    Product Code
    Regulation Number
    880.6885
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROCHEM LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Aldahol® V High Level Disinfectant is intended for the high level disinfection of reusable, clean, heat-sensitive, semi-critical medical devices which contact intact mucous membranes when the disinfectant is used at or above its minimum recommended concentration of 1.8% glutaraldehyde for 10.0 min at 20℃. Aldahol V High Level Disinfectant is intended for the sterilization of reusable, clean, heatsensitive critical and semi-critical medical devices which contact and potentially penetrate into sterile body areas, for which there is no other practical method of sterilization available with a biological indicator, when the disinfectant is used at or above its minimum recommended concentration of 1.8% glutaraldehyde for 8.0 hrs at 20℃. Aldahol V High Level Disinfectant may be used in a legally marketed, validated, automatic endoscope reprocessor machine or in a manual bucket system.
    Device Description
    Aldahol V High Level Disinfectant (HLD) is an aqueous solution that requires the combination of two parts: the light yellow unactivated Aldahol V HLD solution, packaged in gallon-sized containers, and a red Activator Buffer Salt Solution packaged in twelve ounce containers. Once activated, the red/red-orange Aldahol V HLD as initially manufactured contains 3.40 ± 0.2% w/w glutaraldehyde and 20.1% ± 1% w/w isopropanol in a buffered salt solution with a pH value of about 7.6 to about 7.9, containing a surfactant, and potassium acetate salts all intended to enhance the antimicrobial activity of the solution.
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