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510(k) Data Aggregation

    K Number
    K240745
    Device Name
    ID Free Personal Lubricant
    Manufacturer
    Westridge Laboratories, Inc.
    Date Cleared
    2024-09-27

    (192 days)

    Product Code
    NUC, AST
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Westridge Laboratories, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ID Free® Personal Lubricant is for or penile, anal and/or vaginal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprenecondoms. This product is not compatible with polyurethane condoms.
    Device Description
    ID Free® Personal Lubricant is a personal lubricant, for penile, anal and/or vaginal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is intended for over-the-counter use. The device is a non-sterile water based personal lubricant with a clear, odorless formulation. The device is packaged in nonsterile 8.5 fl. oz/250 ml plastic/PET bottles with a screw-on cap and flip top closure, or in 0.14 fl. oz/4 ml foil sachets. The device is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product is not a contraceptive and does not contain a spermicide. The device formulation consists of water, propanediol, hydroxyethyl cellulose, carbomer, PEG-45M, tetrahydroxypropyl ethylenediamine, EDTA, caprylhydroxamic acid, and sucralose.
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    K Number
    K141767
    Device Name
    ID MILLENNIUM, ID MOMENTS SILICONE
    Manufacturer
    WESTRIDGE LABORATORIES, INC.
    Date Cleared
    2015-03-09

    (251 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    WESTRIDGE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ID® Millennium® is a personal lubricant, for penile and /or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. ID® Moments® Silicone is a personal lubricant, for penile and /or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
    Device Description
    ID® Millennium® is non-sterile, an over-the-counter silicone based personal lubricant, formulated to be clear, non-irritating, non-greasy natural and odorless. This device is silicone soluble liquid for use as a personal lubricant. ID® Millennium® Personal Lubricant contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device. ID® Millennium® Personal Lubricant is neither a contraceptive nor a spermicide. The device is available in the following variant personal lubricant formulas: ID® Millennium® and ID Moments® Silicone. ID® Millennium® Personal Lubricant is provided in plastic/PET bottles with screw-on cap, flip top closure, pump dispensers, and foils.
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