FDA.reportPublic FDA data

JO All-In-One Massage Glide - Fragrance Free - Massage 4 floz / 120 mL

Primary DI
10796494000332
Brand
JO All-In-One Massage Glide - Fragrance Free - Massage 4 floz / 120 mL
Company
CC Wellness LLC
Model
40023
Device description
Silicone-Based Lubricant
Published
2022-09-08
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
NUCLubricant, Personal

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180083000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180083000Silicone Personal Lubricant, ALL-IN-ONEUnited Consortium2018-04-09NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10796494000332PackageGS112In Commercial Distribution
00796494000335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1079649400033210796494000332
00796494000335007964940003357964940003350796494000335

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
false
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874950815Hyaluronic Acid Vaginal Suppository (HA 10 mg)HUDI PHARMA SRLNUC2026-09-06
00796494750216LL Water-Based 5mLCC Wellness LLCNUC2026-09-04
00796494750223LL Water-Based 5mL Foil - 10pkCC Wellness LLCNUC2026-09-04
00796494750230LL 3X Anal 5mLCC Wellness LLCNUC2026-09-04
00796494750247LL Silky Silicone 5mLCC Wellness LLCNUC2026-09-04
08721325867261SVibeAMOREO EUROPE SOCIEDAD LIMITADA.NUC2026-08-25
00651277001681Cock Oil - Silicone 9ozCockOil LLCNUC2026-08-21
00651277069001Cock Oil - Natural Agape 2ozCockOil LLCNUC2026-08-21
06974586081637BEISAR, Water Solubility Human Body LubricantDongguan Yanxuan Biotechnology Co., Ltd.NUC2026-08-19
06979879080199RawTouchShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080205RawTouchShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080212RawTouchShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080229RawTouchShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080366RawTouchShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080373HANIDOLLShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080380TantalyShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080397Wet StuffShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
00860002995304HYDRADOSEMD LABS LLCNUC2026-08-01
06936684210333S Shock SharkGuangzhou Haoyimai Trading Co., Ltd.NUC2026-07-30
06936684210340S Shock SharkGuangzhou Haoyimai Trading Co., Ltd.NUC2026-07-30
06936684210357S Shock SharkGuangzhou Haoyimai Trading Co., Ltd.NUC2026-07-30
00855859003319ViaSolv Wellness, LLCNUC2026-07-29
00850026643275Rock CandyPRIVATE LABEL PRODUCTIONS LLCNUC2026-07-17
00198715540161LavaLava IntimatesNUC2026-07-14
06974586081675BEISAR, Water Solubility Human Body LubricantDongguan Yanxuan Biotechnology Co., Ltd.NUC2026-07-14
00199284921726Urge Silicone Personal LubricantUrge Cream LLCNUC2026-07-08
00827160117436pjur NATURE TouchPjur Group Luxembourg SANUC2026-07-03
06979879080236ArousellubeShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080250ArousellubeShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080267ArousellubeShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03