FDA.reportPublic FDA data

BabyDance

Primary DI
00896593002497
Brand
BabyDance
Company
FAIRHAVEN HEALTH, L.L.C.
Model
2
Device description
Fertility lubricant, 40 gram tube with 10 applicators
Published
2020-05-07
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
K162319000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162319000BabyDance Fertility LubricantFairhaven Health, LLC2017-04-28PEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00896593002497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896593002497008965930024978965930024970896593002497

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
(360)543-7888suzanne@fairhavenhealth.com

Regulatory Flags#

DUNS number
063041611
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00896593002220BabyDance12017-11-09
00896593002480BabyDance32020-05-07
00896593002503Sage Personal Moisturizer and Lubricant12020-05-07

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