FDA.reportPublic FDA data

SVAKOM VE water based lubricant

Primary DI
06959633106327
Brand
SVAKOM VE water based lubricant
Company
Shenzhen Yongquan Medical Devices Co., Ltd.
Model
5.3FL.OZ/150g
Device description
This water-based warming lubricant glides smoothly over skin, deliveringlasting moisture with a gentle heat that builds as you move. Lightweight,comfortable, and easy to rinse, it's made for moments that deserve alittle extra
Published
2026-05-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
06959633106327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06959633106327069596331063276959633106327

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 Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Storage Environment Temperature56 Degrees Fahrenheit86 Degrees Fahrenheit

Regulatory Flags#

DUNS number
550369639
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06979879080199RawTouch10 FL.OZ(300ML)2026-08-14
06979879080205RawTouch10 FL.OZ(300ML)2026-08-14
06979879080212RawTouch10 FL.OZ(300ML)2026-08-14
06979879080229RawTouch17 FL.OZ(500ML)2026-08-14
06979879080366RawTouch4g2026-08-14
06979879080373HANIDOLL16 FL.OZ2026-08-14
06979879080380Tantaly1.01FL.OZ(30ml)2026-08-14
06979879080397Wet Stuff150g2026-08-14
06979879080236Arousellube3g*102026-07-03
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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