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510(k) Data Aggregation
K Number
K190150Device Name
Sage 2-in-1 Personal Lubricant and Moisturizer
Manufacturer
Fairhaven Health, LLC
Date Cleared
2019-07-16
(167 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Fairhaven Health, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sage 2-in-1 Personal Lubricant and Moisturizer is 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 condoms. This product is not compatible with polyisoprene or polyurethane condoms
Device Description
Sage 2-in-1 Personal Lubricant and Moisturizer™ is a non-sterile, water-soluble personal lubricant for over-the-counter (OTC) use. The lubricant will be provided in a 1.6 oz tube and will also be supplied with a low-density polyethylene applicator.
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K Number
K162319Device Name
BabyDance Fertility Lubricant
Manufacturer
Fairhaven Health, LLC
Date Cleared
2017-04-28
(252 days)
Product Code
PEB
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Fairhaven Health, LLC
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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