FDA.reportPublic FDA data

DUREX Massage & Play - Intensify 2 in 1 Lubricant - Guarana

Primary DI
00302340876391
Brand
DUREX Massage & Play - Intensify 2 in 1 Lubricant - Guarana
Company
RB Health (us) LLC
Model
Personal Lubricant
Device description
Personal Lubricant
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
K063385000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063385000DUREX PLAY MASSAGE GEL LUBRICANTSsl Americas, Inc.2008-03-10NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10302340876398PackageGS13In Commercial Distribution
20302340876395PackageGS16In Commercial Distribution
00302340876391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030234087639810302340876398
2030234087639520302340876395
00302340876391003023408763913023408763910302340876391

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
Special Storage Condition, Specify00Store at room temperature and avoid excess heat

Contacts#

Phone, Email table
PhoneEmail
+1(800)756-5488xxx@xxx.xxx

Regulatory Flags#

DUNS number
081049410
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
50302340996131Durex Intense003023409961362026-03-02
00067981087956KY Personal Lubricant Jelly000679810890282025-12-09
00067981087963KY Personal Lubricant Jelly000679810891272025-12-09
10067981088059KY Warming Jelly 000679810894792025-12-09
10067981088042KY Warming Jelly 000679810894862025-12-09
10067981993698KY Personal Lubricant Jelly000679819936912025-12-09
10067981993964KY Natural Feeling with Hyaluronic Acid000679819939672025-12-09
10067981993971KY Natural Feeling with Hyaluronic Acid000679819939742025-12-09
10067981993988KY Natural Feeling with Aloe Vera Lubricant000679819939812025-12-09
00067981087253KY Intense CondomsCondom2019-05-30
00067981087260KY Intense CondomsCondom2019-05-30
00067981087277KY Intense CondomsCondom2019-10-14
00067981087758KY Extra Lubricated CondomsCondom2019-06-12
00067981087765KY Intense CondomsCondom2019-06-12
00067981941845KY Touch 2-in-1 Massage Creme & Pleasure GelPersonal Lubricant2016-09-20
00067981962161KY Touch 2-in-1 Massage Creme & Pleasure GelPersonal Lubricant2016-09-20
00067981087925KY UltraGel Personal Lubricant000679810873522016-09-20
00067981087932KY UltraGel Personal Lubricant000679810873762016-09-20
00067981963038KY Natural Feeling with Botanical Essence Lubricant & Massage GelPersonal Lubricant2018-10-31
00067981087178KY Extra Lubricated CondomsCondom2018-10-31

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