FDA.reportPublic FDA data

Diva Lubricator

Primary DI
00841445001111
Brand
Diva Lubricator
Company
Diva International Inc
Model
1
Catalog number
FGBC200201
Device description
This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.
Published
2025-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K182027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182027000Wet Organics Personal LubricantTrigg Laboratories Dba Wet International2018-11-21NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841445000692PackageGS16In Commercial Distribution
20841445000491PackageGS136In Commercial Distribution
00841445001111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084144500069210841445000692
2084144500049120841445000491
00841445001111008414450011118414450011110841445001111

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

Contacts#

Phone, Email table
PhoneEmail
18664443482qaregulatory@divacup.com

Regulatory Flags#

DUNS number
207651758
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841445001425Diva Hot Flash PatchCombo PackFGHW6002012026-10-12
00841445001432Diva Hot Flash PatchRectangleCM500152026-10-12
00841445001449Diva Hot Flash PatchBeanCM500162026-10-12
00050428087701The DivaCupModel B PL6348642026-03-31
00050428088852The DivaCupModel A PL7225372026-03-31
00841445001388Diva Biome Balancer Applicator12026-02-06
00841445001203Diva Cramp Care Patch-FGMC5402012025-11-03
00841445001326DivaCup ImpactModel 0DV0002025-09-01
00841445001333DivaCup ImpactModel 1DV0012025-09-01
00841445001340DivaCup ImpactModel 2DV0022025-09-01
00857538000015The DivaCupModel 1FGCU0101012017-07-27
00857538000022The DivaCupModel 2FGCU0201012017-07-27
00841445000428Diva UnderwearXS-SFGUN060101BK012024-07-17
00841445000435Diva UnderwearM-LFGUN060101BK022024-07-17
00841445000442Diva UnderwearXL-XXLFGUN060101BK032024-07-17
00841445000459Diva Underwear3XL-4XLFGUN060101BK042024-07-17
00841445000466DivaXS-SFGUN060201BK012023-09-29
00841445000473DivaM-LFGUN060201BK022023-09-29
00841445000480DivaXL-XXLFGUN060201BK032023-09-29
00841445000497Diva3XL-4XLFGUN060201BK042023-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00726893119949One TrueGLOBAL PROTECTION CORP.NUC2026-10-07
00726893119956One TrueGLOBAL PROTECTION CORP.NUC2026-10-07
00726893119970One TrueGLOBAL PROTECTION CORP.NUC2026-10-07
20726893120123One TrueGLOBAL PROTECTION CORP.NUC2026-10-07
00860014736827King's Gear Water Based Lube 8 floz / 240 MLLSTX LLCNUC2026-10-01
00850012528593JUICY LIKE A PEACHJoylux, Inc.NUC2026-09-29
00796494750261LL 3x Anal 5mL Foils - 10pkCC Wellness LLCNUC2026-09-24
00796494750278LL Silky Silicone 5mL Foils - 10pkCC Wellness LLCNUC2026-09-24
08859798108670SKYNSURETEX LIMITED - BRANCHNUC2026-09-18
08859798108687SKYNSURETEX LIMITED - BRANCHNUC2026-09-18
08859798108694SKYNSURETEX LIMITED - BRANCHNUC2026-09-18
08859798108700SKYNSURETEX LIMITED - BRANCHNUC2026-09-18
08859798108717SKYNSURETEX LIMITED - BRANCHNUC2026-09-18
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
00651277000004Cock Oil Foil Packet water baseCockOil LLCNUC2026-08-24
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