FDA.reportPublic FDA data

JO H2O Anal - Cooling - Lubricant 2 floz / 60 mL

Primary DI
10796494000738
Brand
JO H2O Anal - Cooling - Lubricant 2 floz / 60 mL
Company
CC Wellness LLC
Model
40210
Device description
Water-Based Personal Lubricant
Published
2022-09-14
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
K210986000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210986000H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure KitCC Wellness, LLC2021-06-10NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10796494000738PackageGS112In Commercial Distribution
00796494000731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1079649400073810796494000738
00796494000731007964940007317964940007310796494000731

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
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
10796494420529JO - Lubricant - Bake Shoppe - Frosted Cupcake - 2oz420522026-01-23
10796494420536JO - Lubricant - Bake Shoppe - Peach Cobbler - 2oz420532026-01-23
10796494750190JO - Foil - Bake Shoppe - Orange Creampuff - 5ml750192026-01-23
00796494407769LubeLife - Water-based 8oz - Retail - 3pk40776R2026-01-16
00796494407899LubeLife - Strawberry 8oz - Retail - 3pk40789R2026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06979879080298Oye JoyShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080304Oye JoyShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080311TantalyShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080328TantalyShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080342SyronosShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
20726893120482Mixed PleasureGLOBAL PROTECTION CORP.NUC2026-06-04
00796494006160Williams-Trading/Cloud 9 Water-Based 4ozCC Wellness LLCNUC2026-06-02
00796494006177Williams-Trading/Cloud 9 Water-Based 8ozCC Wellness LLCNUC2026-06-02
00796494006184Williams-Trading/Cloud 9 Cum Lubricant 8ozCC Wellness LLCNUC2026-06-02
00796494404089JO Cumplay 4ozCC Wellness LLCNUC2026-06-02
00087701190797good neighbor pharmacyAmerisourcebergen Drug CorporationNUC2026-06-01
00787651760643AZOi-Health, Inc.NUC2026-05-29
00796494455043LL Water-Based Gallon LubricantCC Wellness LLCNUC2026-05-28
08887500730017SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08887500730024SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08887500730031SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08859798108090LIFESTYLESSURETEX LIMITED - BRANCHNUC2026-01-27
20011509061328VagisilCombe IncorporatedNUC2026-01-26
00067981089127KY Personal Lubricant JellyRECKITT BENCKISER LLCNUC2025-12-09
00067981089486KY Warming JellyRECKITT BENCKISER LLCNUC2025-12-09
00067981952292KY Intense Pleasure GelRECKITT BENCKISER LLCNUC2025-12-09
00067981993691KY Personal Lubricant JellyRECKITT BENCKISER LLCNUC2025-12-09
00067981993738KY Personal Lubricant JellyRECKITT BENCKISER LLCNUC2025-12-09
00067981993967KY Natural Feeling with Hyaluronic AcidRECKITT BENCKISER LLCNUC2025-12-09
00067981993974KY Natural Feeling with Hyaluronic AcidRECKITT BENCKISER LLCNUC2025-12-09
00067981993981KY Natural Feeling with Aloe Vera LubricantRECKITT BENCKISER LLCNUC2025-12-09