FDA.reportPublic FDA data

Arousellube

Primary DI
06979879080236
Brand
Arousellube
Company
Shenzhen Yongquan Medical Devices Co., Ltd.
Model
3g*10
Device description
Water-soluble Personal Lubricant is a waterbased personal lubricant, for penile, vaginal application andanus,intended to lubricate and moisturize, to enhance the easeand comfort of intimate sexual activity and supplement thebody' s natural lubrication. This product is not compatible withnatural rubber latex, polyurethane, and polyisoprene condoms
Published
2026-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
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
K251773000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251773000Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.)Shenzhen Yongquan Medical Devices Co., Ltd.2025-09-09NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06979879080236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06979879080236069798790802366979879080236

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal lubricantA non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
550369639
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
true
Expiration date on label
true
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
06979879080250Arousellube100g2026-07-03
06979879080267Arousellube125g2026-07-03
06979879080298Oye Joy3.5 FL.OZ(100ml)2026-07-03
06979879080304Oye Joy3.5 FL.OZ(100ml)2026-07-03
06979879080311Tantaly8.8 FL.OZ(250g)2026-07-03
06979879080328Tantaly17.6 FL.OZ(500g)2026-07-03
06979879080342Syronos10.5 FL.OZ(300g)2026-07-03
06959633106327SVAKOM VE water based lubricant 5.3FL.OZ/150g2026-05-07
06959633106396KAOTIKLABS VE water based lubricant5.3FL.OZ/150g2026-05-07
06977880050309DRYWELL WATER SOLUBILITY HUMAN BODY LUBRICANT200ml2026-05-07
06977880050316DRYWELL WATER SOLUBILITY HUMAN BODY LUBRICANT220ML2026-05-07
06979879080014 NO FORGET LOVE200ml2026-03-26
06979879080021 NO FORGET LOVE Water Soluble Personal Lubricant200ml2026-05-07
06979879080038 NO FORGET LOVE Water Soluble Personal Lubricant200ml2026-05-07
06979879080045 NO FORGET LOVE Water Soluble Personal Lubricant200ml2026-05-07
06979879080052 NO FORGET LOVE Water Soluble Personal Lubricant200ml2026-05-07
06979879080069 NO FORGET LOVE Water Soluble Personal Lubricant200ml2026-05-07
06979879080076NO FORGET LOVE Water Soluble Personal Lubricant200ml2026-05-07
06979879080083 NO FORGET LOVE200ml2026-03-26
06979879080113 NO FORGET LOVE Water Soluble Personal Lubricant200ml2026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827160117436pjur NATURE TouchPjur Group Luxembourg SANUC2026-07-03
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
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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
00067981089479KY Warming JellyRECKITT BENCKISER LLCNUC2025-12-09