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
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
00841445001678Diva Disc1FGCU0501012023-04-27
00857538000237The DivaCupModel 0FGCU0001012018-02-23
00050428645598The DivaCupModel A PL7225372024-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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 JellyRB Health (us) LLCNUC2025-12-09
00067981089486KY Warming Jelly RB Health (us) LLCNUC2025-12-09
00067981952292KY Intense Pleasure GelRB Health (us) LLCNUC2025-12-09
00067981993691KY Personal Lubricant JellyRB Health (us) LLCNUC2025-12-09
00067981993738KY Personal Lubricant JellyRB Health (us) LLCNUC2025-12-09
00067981993967KY Natural Feeling with Hyaluronic AcidRB Health (us) LLCNUC2025-12-09
00067981993974KY Natural Feeling with Hyaluronic AcidRB Health (us) LLCNUC2025-12-09
00067981993981KY Natural Feeling with Aloe Vera LubricantRB Health (us) LLCNUC2025-12-09
30726893210043One MoveGLOBAL PROTECTION CORP.NUC2025-11-13
00016169700057Nauox Yin YangMAYER LABORATORIES, INC.NUC2025-10-06
00016169700064Nauox Holy HoneyMAYER LABORATORIES, INC.NUC2025-10-06
00016169700071Nauox Dulce DreamsMAYER LABORATORIES, INC.NUC2025-10-06
00016169700088Nauox Sweet HavenMAYER LABORATORIES, INC.NUC2025-10-06
00016169700095Naoux Agave NectarMAYER LABORATORIES, INC.NUC2025-10-06
00016169700194Femme GlydeMAYER LABORATORIES, INC.NUC2025-10-06
00198715811087Kindra V LubeMAYER LABORATORIES, INC.NUC2025-10-06
07964944077692LubeLife - Water-based 8oz - Retail - 3pkCC Wellness LLCNUC2025-07-22
07964944078996LubeLife - Strawberry 8oz - Retail - 3pkCC Wellness LLCNUC2025-07-22
00067981993783K-Y® Hydrablend RB Health (us) LLCNUC2025-07-10
08032595872429REVAREEFARMA DERMA SRLNUC2025-06-26
08032595872436REVAREEFARMA DERMA SRLNUC2025-06-26
08859798106058LIFESTYLESSURETEX LIMITED - BRANCHNUC2025-06-18
00067981994155KY Warming Liquid LubricantRB Health (us) LLCNUC2025-06-01
00067981994162KY Yours & Mine Couples LubricantRB Health (us) LLCNUC2025-06-01