FDA.reportPublic FDA data

Regenesis Fertility Lubricant

Primary DI
00893268000802
Brand
Regenesis Fertility Lubricant
Company
GOOD CLEAN LOVE, INC.
Model
5mL
Catalog number
200401
Device description
Regenesis Fertility Lubricant is a personal lubricant for penile and/or vaginal application, intended to moisturize andlubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.Regenesis Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceivecouples. Regenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms. It is notcompatible with polyurethane condoms.Regenesis Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic andtherapeutic devices during fertility interventions and reproductive medicine.
Published
2023-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
PEBLubricant, Personal, Gamete, Fertilization, And Embryo Compatible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEBLubricant, Personal, Gamete, Fertilization, And Embryo CompatibleObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190872000BioGenesis Fertility LubricantGood Clean Love, Inc.2019-11-07PEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850014621971PackageGS1100In Commercial Distribution
00850044065097PackageGS1100In Commercial Distribution
00893268000802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014621971008500146219718500146219710850014621971
00850044065097008500440650978500440650970850044065097
00893268000802008932680008028932680008020893268000802

GMDN Terms#

Term, Definition table
TermDefinition
Sexual lubricantA substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
153909531
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014621070Rehydrate Vaginal Gel5 mL2006012022-04-14
00893268000673Regenesis Fertility Lubricant2oz2004022022-04-12
00893268000680Rehydrate Vaginal Gel2oz2006022022-04-14
00850044065172Naked Coconut1.5oz7006502025-06-24
00850044065219Naked Coconut3ozE700750, C7007502025-06-24
00893268000253BioNude Ultra Sensitive Personal Lubricant3oz2007042022-04-12
00893268000604Almost Naked4oz.2001042016-10-13
00893268000222Restore Moisturizing Vaginal Gel2oz.5001022017-09-25
00893268000109Almost Naked1.5oz.2001052016-10-13
00850014621773Liquid Lubricant5 mL2005002022-05-18
00850014621780Hybrid Lubricant5 mL2005012022-05-18
00893268000260BioNude Ultra Sensitive Personal Lubricant5 mL2007052022-04-12
00893268000710Restore Moisturizing Vaginal Gel5 mL5001012022-04-12
00850014621940Almost Naked Hint of Mint1.69oz7003502023-07-05
00893268000987Almost Naked5ml2001032016-10-13
00850014621568Hybrid Lubricant1.69oz7002502022-05-09
00893268000239Guilty Pleasure / Cinnamon Vanilla1.5oz.2003052016-10-13
00893268000598Guilty Pleasure / Cinnamon Vanilla4oz.2003042016-10-13
00893268000031Guilty Pleasure / Cinnamon Vanilla5ml 2001062016-10-13
30893268000230Guilty Pleasure / Cinnamon Vanilla1.5oz.2003052016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014330308Baby Boom Fertility Lubricant 2oz tubePERFECT TIMING LUBRICANTS, LLCPEB2026-05-15
00796494006146Beacon Wellness Fertility Lubricant 4ozCC Wellness LLCPEB2026-01-07
30796494006147Beacon Wellness Fertility Lubricant 4ozCC Wellness LLCPEB2026-01-07
00810028776166FridaFridababy, LLCPEB2024-09-12
00796494004319Pure Romance - Conceptria Lubricant - 2oz/60mlCC Wellness LLCPEB2024-01-12
10796494004316Pure Romance - Conceptria Lubricant - 2oz/60mlCC Wellness LLCPEB2024-01-12
00796494004029LubeLife - Water-based - 2oz / 60mlCC Wellness LLCPEB2023-09-25
00796494004043LubeLife - Water-based - 2oz / 60mlCC Wellness LLCPEB2023-09-25
00796494002032Doc Johnson – Pop Lube by Tantus – TTC - 4 floz 120 mLCC Wellness LLCPEB2023-05-12
00796494002650Gen X - Procreate - 4 ozCC Wellness LLCPEB2023-05-12
00796494002766GenX – Fertility Friendly Lube- 2ozCC Wellness LLCPEB2023-05-12
00796494002919Modern Fertility - Fertility-Friendly Lubricant - No Parabens or Fragrance - 1 oCC Wellness LLCPEB2023-05-12
00796494002926Modern Fertility - Fertility-Friendly Lubricant - No Parabens or Fragrance - 1 oCC Wellness LLCPEB2023-05-12
00796494002933Natalist – Fertility Friendly Rose Water – 2ozCC Wellness LLCPEB2023-05-12
00796494002940Natalist – Fertility Friendly Rose Water wUC – 2ozCC Wellness LLCPEB2023-05-12
00796494003312Promescent - Fertility Lubricant - 2ozCC Wellness LLCPEB2023-05-12
10796494002039Doc Johnson – Pop Lube by Tantus – TTC - 4 floz 120 mLCC Wellness LLCPEB2023-05-12
10796494002657Gen X - Procreate - 4 ozCC Wellness LLCPEB2023-05-12
00796494002773GenX – Fertility Friendly Lube- 2ozCC Wellness LLCPEB2023-05-12
10796494002916Modern Fertility - Fertility-Friendly Lubricant - No Parabens or Fragrance - 1 oCC Wellness LLCPEB2023-05-12
10796494002923Modern Fertility - Fertility-Friendly Lubricant - No Parabens or Fragrance - 1 oCC Wellness LLCPEB2023-05-12
10796494002930Natalist – Fertility Friendly Rose Water – 2ozCC Wellness LLCPEB2023-05-12
10796494002947Natalist – Fertility Friendly Rose Water wUC – 2ozCC Wellness LLCPEB2023-05-12
10796494003319Promescent - Fertility Lubricant - 2ozCC Wellness LLCPEB2023-05-12
00796494001639#LubeLife – Trying to Conceive (TTC) – 2ozCC Wellness LLCPEB2022-09-16
10796494001636#LubeLife – Trying to Conceive (TTC) – 2ozCC Wellness LLCPEB2022-09-16
00796494000458JO Actively Trying (TTC) - Original - Lubricant 4 floz / 120 mLCC Wellness LLCPEB2022-09-13
10796494000455JO Actively Trying (TTC) - Original - Lubricant 4 floz / 120 mLCC Wellness LLCPEB2022-09-13
00850029375050Modern Fertility LubricantMODERN HEALTHPEB2022-06-07
00893268000673Regenesis Fertility LubricantGOOD CLEAN LOVE, INC.PEB2022-04-12