FDA.reportPublic FDA data

Conceive Plus

Primary DI
09337213008464
Brand
Conceive Plus
Company
Sasmar Pharmaceuticals SPRL
Model
3x4g
Catalog number
880846
Device description
Fertility Lubricant
Published
2016-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K131355000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131355000CONCEIVE PLUSSasmar, Inc.2013-11-07PEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19337213008461PackageGS16In Commercial Distribution
29337213008468PackageGS112In Commercial Distribution
09337213008464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1933721300846119337213008461
2933721300846829337213008468
09337213008464093372130084649337213008464

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal lubricantA non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
773 942-0030helpdesk@sasmar.com

Regulatory Flags#

DUNS number
370696875
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09337213008143Sasmar Classic50ml8808142016-10-03
09337213008150Sasmar Warming50ml8808152016-10-03
09337213008167Sasmar Pina Colada 50ml8808162016-10-03
09337213008174Sasmar Strawberry50ml8808172016-10-03
09337213008181Sasmar Original60ml8808182016-10-03
09337213008198Sasmar Cherry50ml8808192016-10-03
09337213008204Sasmar Vanilla50ml8808202016-10-03
09337213008211Sasmar Classic60ml8808212016-10-03
09337213008228Sasmar Warming60ml8808222016-10-03
09337213008235Sasmar Pina Colada60ml8808232016-10-03
09337213008242Sasmar Strawberry60ml8808242016-10-03
09337213008259Sasmar Cherry60ml8808252016-10-03
09337213008266Sasmar Vanilla60mlK1310842016-10-03
09337213008303Sasmar Melon60ml8808302016-10-03
09337213008310Sasmar Melon50ml8808312016-10-03
09337213008419Conceive Plus30ml8808412016-10-03
09337213008426Conceive Plus75ml8808422016-10-03
09337213008457Conceive Plus8x4g8808452016-10-03
09337213008549Sasmar Classic118ml8808542016-10-03

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