FDA.reportPublic FDA data

Pre-Seed™ Personal Lubricant Fertility Friendly

Primary DI
00855114000992
Brand
Pre-Seed™ Personal Lubricant Fertility Friendly
Company
CHURCH & DWIGHT CO., INC.
Model
00855114000992
Device description
Lubricant
Published
2017-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
K072741000
K193450000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072741000PRE-VA VAGINAL LUBRICANTIngfertility, LLC2008-07-16PEB
K193450000Pre-Seed™ Fertility LubricantChurch & Dwight Co., Inc.2020-07-23PEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855114000992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855114000992008551140009928551140009920855114000992

GMDN Terms#

Term, Definition table
TermDefinition
Sexual lubricantA non-sterile 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. It is normally available [non-prescription] over-the-counter (OTC). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)833-9532Consumer.Relations@churchdwight.com

Regulatory Flags#

DUNS number
001211952
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00022600947219Trojan™ Premium Latex Condoms Ultra Ribbed Ecstasy™000226009472192016-10-14
00022600947325Trojan™ Premium Latex Condoms Ultra Ribbed Ecstasy™000226009473252016-10-13
00022600947400Trojan™ Premium Latex Condoms Ultra Ribbed Ecstasy™000226009474002016-10-13
00022600980506TROJAN™ NaturaLamb™ Luxury Condoms000226009805062016-10-13
00022600987536TROJAN™ NaturaLamb™ Luxury Condoms000226009875362016-10-13
00022600998440TROJAN™ NaturaLamb™ Luxury Condoms000226009984402016-10-13
00022600000600Trojan All The Feels Variety Pack000226000006002020-06-22
00022600000709Trojan All The Feels Variety Pack000226000007092020-07-29
00022600300007Trojan All the Feels Condom000226003000072020-06-10
00022600999492Trojan Variety Pack000226009994922020-07-15
00726893113985Trojan Ultra Thin Condoms007268931139852020-07-07
00726893113992Trojan Ultra Thin Condom007268931139922020-07-16
00726893114005Trojan Ultra Thin Condom007268931140052020-07-08
00726893114043Trojan Magnum007268931140432020-03-12
00726893114098Trojan Magnum Condom007268931140982020-03-27
00726893114104Trojan Enz007268931141042020-03-20
00726893800014Trojan Ultra Thin Condom007268938000142020-09-28
00726893800021Trojan Ultra Ribbed Condom007268938000212020-09-28
00726893800038Trojan Mangum Condom007268938000382020-09-28
00022600019831TROJAN 100CT BULK MIX000226000198312018-10-30

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
00893268000802Regenesis Fertility LubricantGOOD CLEAN LOVE, INC.PEB2023-04-03
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