FDA.reportPublic FDA data

JO Gelato Mint Chocolate 1oz/30ml

Primary DI
B362410220
Brand
JO Gelato Mint Chocolate 1oz/30ml
Company
CC Wellness LLC
Model
41022
Device description
Water-based Personal Lubricant
Published
2018-05-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K172447000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172447000JO Gelato Flavored Personal LubricantsUnited Consortium2017-10-31NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851271008048PackageGS112In Commercial Distribution
B362410221PackageHIBCC12Not in Commercial Distribution
B362410220PreviousHIBCC0
00851271008031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851271008048008512710080488512710080480851271008048
00851271008031008512710080318512710080310851271008031

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

Regulatory Flags#

DUNS number
067692292
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00796494750216LL Water-Based 5mL750212026-09-04
00796494750223LL Water-Based 5mL Foil - 10pk750222026-09-04
00796494750230LL 3X Anal 5mL750232026-09-04
00796494750247LL Silky Silicone 5mL750242026-09-04
00796494006191Kindra - Water-based Lubricant - 3.4oz703092026-06-10
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

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