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510(k) Data Aggregation

    K Number
    K212885
    Device Name
    Actively Trying Personal Lubricant Rose Scented
    Manufacturer
    CC Wellness LLC
    Date Cleared
    2022-02-11

    (154 days)

    Product Code
    PEB
    Regulation Number
    884.5300
    Why did this record match?
    Product Code :

    PEB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Actively Trying Personal Lubricant Rose Scented is a personal lubricant for penile, and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive.This product is compatible with natural rubber latex and polvisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    Actively Trying Personal Lubricant Rose Scented is a clear, semi-viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product is compatible with sperm, oocytes and can be used by couples trying to conceive. Actively Trying Personal Lubricant Rose Scented is sold as an over-the-counter (OTC) product in 4 fl. oz./120 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Hydroxyethylcellulose, Sodium Chloride, Sodium Phosphate, Potassium Phosphate, Propylene Glycol, Chlorphenisen, Fructose, Arabinogalactan, and Rose water (Damascena).
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    K Number
    K212705
    Device Name
    Actively Trying Personal Lubricant Unfragrance
    Manufacturer
    CC Wellness LLC
    Date Cleared
    2022-02-09

    (167 days)

    Product Code
    PEB
    Regulation Number
    884.5300
    Why did this record match?
    Product Code :

    PEB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Actively Trying Personal Lubricant Unfragranced is a personal lubricant for penile, and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. This product is compatible with natural rubber latex and polvisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    Actively Trying Personal Lubricant Unfragranced is a clear, semi-viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product is compatible with sperm, oocytes and can be used by couples trying to conceive. Actively Trying Personal Lubricant Unfragranced is sold as an over-the-counter (OTC) product in 4 fl. oz./120 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Hydroxyethylcellulose, Sodium Chloride, Sodium Phosphate, Potassium Phosphate, Propylene Glycol, Chlorphenisen, Fructose and Arabinogalactan.
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    K Number
    K193450
    Device Name
    Pre-Seed™ Fertility Lubricant
    Manufacturer
    Church & Dwight Co., Inc.
    Date Cleared
    2020-07-23

    (223 days)

    Product Code
    PEB
    Regulation Number
    884.5300
    Why did this record match?
    Product Code :

    PEB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pre-Seed™ Fertility Lubricant 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. Pre-Seed™ Fertility Lubricant is compatible with sperm, oocytes, and can be used by trying to conceive couples. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. Pre-Seed™ Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.
    Device Description
    Pre-Seed™ Fertility Lubricant is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubrication. The product is also compatible with sperm, oocytes, and embryos, can be used by trying to conceive couples, and can also be used to lubricate diagnostic and therapeutic devices during fertility interventions and reproductive medicine. Pre-Seed™ Fertility Lubricant is packaged in a High-Density Polyethylene tube with a Polypropylene closure. A foil seal is present over the tube opening under the cap closure. The provided with single-use, piston type, Low Density Polyethylene applicators for delivering the product to the vagina.
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    K Number
    K190872
    Device Name
    BioGenesis Fertility Lubricant
    Manufacturer
    Good Clean Love, Inc.
    Date Cleared
    2019-11-07

    (218 days)

    Product Code
    PEB
    Regulation Number
    884.5300
    Why did this record match?
    Product Code :

    PEB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioGenesis Fertility Lubricant 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. BioGenesis Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples. BioGenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. BioGenesis Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.
    Device Description
    BioGenesis Fertility Lubricant is water-based formula with ingredients including lactic acid, hydroxyethylcellulose, sodium chloride, potassium sorbate, sodium benzoate, potassium chloride, sorbic acid, magnesium chloride, and calcium chloride. The product is provided in a tube container and has a gel consistency. Its specifications are listed in Table 1 below. The lubricant is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. It is also compatible with compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples.
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    K Number
    K182585
    Device Name
    JO Actively Trying Personal Lubricant
    Manufacturer
    United Consortium
    Date Cleared
    2019-04-26

    (218 days)

    Product Code
    PEB
    Regulation Number
    884.5300
    Why did this record match?
    Product Code :

    PEB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JO Actively Trying Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and can be used by couples trying to conceive. This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.
    Device Description
    JO Actively Trying Personal Lubricant is a clear, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. This device is a non-sterile personal lubricant for penile and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles are capped with silver disc top caps. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Propylene Glycol, Hydroxyethylcellose, Fructose, Arabinogalactan, Sodium Phosphate, Salt, Potassium Phosphate, Methylparaben.
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    K Number
    K162319
    Device Name
    BabyDance Fertility Lubricant
    Manufacturer
    Fairhaven Health, LLC
    Date Cleared
    2017-04-28

    (252 days)

    Product Code
    PEB
    Regulation Number
    884.5300
    Why did this record match?
    Product Code :

    PEB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BabyDance Fertility Lubricant 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. BabyDance Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples. BabyDance Fertility Lubricant is compatible with natural rubber latex and polyurethane condoms. BabyDance Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.
    Device Description
    This device is a non-sterile, water-based personal lubricant for vaginal and/or penile application. The formulation does not harm sperm function and has a pH and osmolality that are physiologic ("balanced") to that of fertile cervical mucus and semen. The device is compatible with latex and polyurethane condoms. BabyDance Fertility Lubricant™ is formulated using purified water, cetyl hydroxyethylcellulose, hypromellose, carbomer homopolymer type B, sodium phosphate, potassium phosphate, sodium chloride, xvlose, sodium hydroxide, phenethyl alcohol, caprylyl glycol, and Salvia sclarea. This device is supplied with an applicator. The device specifications for the BabyDance Fertility Lubricant™ include appearance, odor, pH, viscosity, osmolality, total aerobic microbial count, total yeast and mold count, absence of pathogenic orqanisms (Escherichia coli, Staphylococcus. aureus, Salmonella, Pseudomonas aeruginosa, and Candida albicans), endotoxin, mouse embryo assay (MEA), and human sperm survival assay (HSSA). These specifications were evaluated during the length of the proposed shelf-life and will be tested before lot release.
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    K Number
    K141132
    Device Name
    ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT
    Manufacturer
    BIOFILM, INC.
    Date Cleared
    2015-01-09

    (253 days)

    Product Code
    PEB
    Regulation Number
    884.5300
    Why did this record match?
    Product Code :

    PEB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Astroglide® TTC 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. Astroglide TTC is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. Astroglide® TTC is compatible with natural rubber latex, polyisoprene and polyurethane condoms.
    Device Description
    Astroglide® TTC Fertility Friendly Personal Lubricant is a non-sterile, clear, and water-based personal lubricant for penile and/or vaginal application. Astroglide® TTC has a pH and osmolarity that is compatible with sperm survival and migration. The device is packaged in pre-filled tube applicators which may be used for single use intra-vaginal application or applied directly to penis or vagina. Astroglide® TTC is formulated using water, propylene glycol, hydroxyethylcellulose, fructose, methylparaben, sodium phosphate, potassium phosphate, propyl paraben, galactose, and sodium hydroxide. This device is batch lot tested for appearance, color, viscosity, pH, microbial count, osmolality, endotoxin, mouse embryo assay and human sperm survival assay.
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    K Number
    K131355
    Device Name
    CONCEIVE PLUS
    Manufacturer
    SASMAR INC
    Date Cleared
    2013-11-07

    (181 days)

    Product Code
    PEB
    Regulation Number
    884.5300
    Why did this record match?
    Product Code :

    PEB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CONCEIVE PLUS® 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. CONCEIVE PLUS® is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. This product can be used in fertility interventions to facilitate entry of diagnostic and therapeutic devices into the vaginal cavity. CONCEIVE PLUS® is compatible with natural rubber latex and polyurethane condoms. CONCEIVE PLUS® is not for use with polyisoprene condoms.
    Device Description
    CONCEIVE PLUS® is non-sterile water-based personal lubricant and vaginal moisturizer that is isotonic. The device contains calcium and magnesium ions and is formulated to meet a pH range that is compatible with sperm survival and migration. CONCEIVE PLUS® supplements the body's own natural moisture and is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. The device is packaged in a plastic tube or a pre-filled applicator for intra-vaginal application. CONCEIVE PLUS® is formulated using Deionized Water, Hypromellose, Sodium Phosphate, Sodium dihydrogen Phosphate, Potassium Chloride, Sodium Chloride, Magnesium Chloride, Calcium Chloride, Glycerol and Methylparaben. This device is batch lot tested for appearance, color, odor, viscosity, osmolarity, specific gravity, pH, microbial limits, endotoxin, mouse embryo assay, and human sperm survival assay.
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    K Number
    K072741
    Device Name
    PRE-VA VAGINAL LUBRICANT
    Manufacturer
    INGFERTILITY, LLC
    Date Cleared
    2008-07-16

    (293 days)

    Product Code
    PEB
    Regulation Number
    884.5300
    Why did this record match?
    Product Code :

    PEB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - To lubricate vaginal tissues to facilitate entry of diagnostic or therapeutic devices including those used in fertility interventions. Pre~Va may be applied directly to the device or may be deposited intravaginally using the applicator, prior to the insertion of diagnostic or therapeutic devices used in fertility interventions. - As a personal lubricant Pre-Va supplements the body's own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. Pre~Va is safe for use by couples who are trying to conceive and may be applied to vaginal or penile tissues for lubrication and moisturization purposes. It is compatible with latex and polyurethane condoms.
    Device Description
    This product is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubricating fluids. Pre~Va is used to lubricate vaginal tissues to facilitate entry of diagnostic or therapeutic devices including those used in fertility interventions. It is also used as a personal lubricant to supplement the body's own natural lubricating fluids and to enhance the comfort of intimate sexual activity. The formulation does not harm sperm function and has a pH and osmolarity that are physiologic ("balanced") to that of fertile cervical mucus and semen. The product is compatible with latex and polyurethane condoms.
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    K Number
    K051436
    Device Name
    PRE' VAGINAL LUBRICANT
    Manufacturer
    INGFERTLITY, LLC
    Date Cleared
    2006-10-13

    (499 days)

    Product Code
    PEB
    Regulation Number
    884.5300
    Why did this record match?
    Product Code :

    PEB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - To lubricate vaginal tissues to facilitate entry of a diagnostic or therapeutic a devices including fertility interventions. - As a personal lubricant to supplement the body's own natural lubricating As a personal labriount to cappion and to enhance the ease and comfort nfinate sexual activity. This lubricant may be safely applied to vaginal or penile tissues for lubrication and moisturization purposes. It is also compatible with latex and polyurethane condoms.
    Device Description
    This product is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubricating fluids. This product may be used to facilitate entry of diagnostic or therapeutic devices, enhance the comfort of intimate sexual activity, or provide personal lubrication when vaginal dryness causes discomfort. The formulation does not harm sperm function and is pH balanced to match fertile cervical mucus. The product is compatible with latex and polyurethane condoms.
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