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510(k) Data Aggregation
K Number
K131355Device Name
CONCEIVE PLUS
Manufacturer
SASMAR INC
Date Cleared
2013-11-07
(181 days)
Product Code
PEB
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
SASMAR INC
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
K131084Device Name
SASMAR ORIGINAL, SASMAR CLASSIC
Manufacturer
SASMAR INC
Date Cleared
2013-09-13
(148 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
SASMAR INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SASMAR® CLASSIC 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.
SASMAR® ORIGINAL 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.
SASMAR® VANILLA 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.
SASMAR® WARMING 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.
SASMAR® CHERRY 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.
SASMAR® MELON 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, polylsoprene, and polyurethane condoms.
SASMAR® PINA COLADA 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.
SASMAR® STRAWBERRY 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
SASMAR® ORIGINAL is a non-sterile silicone based personal lubricant for penile and/or vaginal application intended to facilitate condom use, provide additional moisture to relieve vaginal dryness and enhance pleasure during sexual intimacy. The device may be used as a massage lotion and is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. This product is provided in a plastic pump dispenser or a foil laminate sachet and is available over-the-counter.
SASMAR® CLASSIC is a non-sterile water-based personal lubricant for penile and/or vaginal application intended to facilitate condom use, provide additional moisture to relieve vaginal dryness and enhance pleasure during sexual intimacy. The formula is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The device is available in the following variant personal lubricant formulas: SASMAR® Warming, SASMAR® Vanilla, SASMAR® Melon, SASMAR® Cherry, SASMAR® Strawberry or SASMAR® Pina Colada. This product is provided in a plastic pump dispenser, a plastic tube with flip-top closure or a foil laminate sachet and is available over-the-counter.
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