FDA.reportPublic FDA data

Pure Romance - Conceptria Lubricant - 2oz/60ml

Primary DI
10796494004316
Brand
Pure Romance - Conceptria Lubricant - 2oz/60ml
Company
CC Wellness LLC
Model
72249
Device description
Water-Based Personal Lubricant
Published
2024-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10796494004316PackageGS112In Commercial Distribution
20796494004313PackageGS172In Commercial Distribution
00796494004319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1079649400431610796494004316
2079649400431320796494004313
00796494004319007964940043197964940043190796494004319

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
067692292
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00796494006160Williams-Trading/Cloud 9 Water-Based 4oz721252026-06-02
00796494006177Williams-Trading/Cloud 9 Water-Based 8oz748232026-06-02
00796494006184Williams-Trading/Cloud 9 Cum Lubricant 8oz748242026-06-02
00796494404089JO Cumplay 4oz404082026-06-02
00796494455043LL Water-Based Gallon Lubricant455042026-05-28
00796494003336Romantix Lube It Silicone lube 4oz705012023-05-12
00796494408292LL - 3X Anal International - 8oz / 240mL40829-INT2026-05-05
00796494408513LL Pickle Lubricant 8oz408512026-04-23
00796494701614LL Pickle Lubricant 10mL Foil701612026-04-23
00796494001059JO - Champagne Flavored Lubricant - 2 floz 60 mL420152022-09-14
00796494420515JO - Lubricant - Bake Shoppe - Orange Creampuff- 2oz420512026-01-23
00796494420522JO - Lubricant - Bake Shoppe - Frosted Cupcake - 2oz420522026-01-23
00796494420539JO - Lubricant - Bake Shoppe - Peach Cobbler - 2oz420532026-01-23
00796494750193JO - Foil - Bake Shoppe - Orange Creampuff - 5ml750192026-01-23
10796494420512JO - Lubricant - Bake Shoppe - Orange Creampuff- 2oz420512026-01-23
10796494420529JO - Lubricant - Bake Shoppe - Frosted Cupcake - 2oz420522026-01-23
10796494420536JO - Lubricant - Bake Shoppe - Peach Cobbler - 2oz420532026-01-23
10796494750190JO - Foil - Bake Shoppe - Orange Creampuff - 5ml750192026-01-23
00796494407769LubeLife - Water-based 8oz - Retail - 3pk40776R2026-01-16
00796494407899LubeLife - Strawberry 8oz - Retail - 3pk40789R2026-01-16

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
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
00893268000673Regenesis Fertility LubricantGOOD CLEAN LOVE, INC.PEB2022-04-12