FDA.reportPublic FDA data

Family Wellness Personal Lubricant Jelly

Primary DI
00032251673276
Brand
Family Wellness Personal Lubricant Jelly
Company
Family Dollar Stores
Model
939505
Published
2020-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NUCLubricant, Personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUCLubricant, PersonalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001077000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001077000LUBRIGEL PERSONAL LUBRICANTSheffield Laboratories, Div. of Faria Limited, LLC2000-08-02NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00032251673276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00032251673276000322516732760322516732760032251673276

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
117310689
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00032251578113Family Wellness099901086-9142020-01-27
00032251689659FAMILY WELLNESSSKU9037562025-08-01
00032251689666FAMILY WELLNESSSKU9395042025-08-01
00032251689888FAMILY WELLNESSSKU9976692025-08-01
20032251689653FAMILY WELLNESSSKU9397562025-08-01
10032251689663FAMILY WELLNESSSKU9395042025-08-01
10032251689885FAMILY WELLNESSSKU9976692025-08-01
00032251627620Family Wellness9160612020-08-07
00032251627910Family Wellness9995772020-07-09
00032251921612Family Wellness99957786-359FD2023-10-06
00032251921629Family Wellness91606186-3522023-10-06
00032251057489Family Wellness03225105748909088262020-02-28
00032251057502Family Wellness03225105750209088282020-02-28
00032251057847Family Wellness03225105784709032212020-02-28
00032251058158Family Wellness03225105815809108672020-02-28
00032251911798Family Wellness9028072024-07-08
00032251911804Family Wellness9028062024-07-08
00032251911842Family Wellness9398562024-07-08
00032251911859Family Wellness9996002024-07-08
00032251911866Family Wellness9999862024-07-08

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00796494750247LL Silky Silicone 5mLCC Wellness LLCNUC2026-09-04
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