FDA.reportPublic FDA data

Diva

Primary DI
00841445000497
Brand
Diva
Company
Diva International Inc
Model
3XL-4XL
Catalog number
FGUN060201BK04
Device description
Diva Period Underwear - BL (Each) - Bikini Black 3XL-4XL
Published
2023-09-29
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
NUQPad, Menstrual, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUQPad, Menstrual, ReusableObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841445000425PackageGS16In Commercial Distribution
20841445000415PackageGS124In Commercial Distribution
00841445000497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084144500042510841445000425
2084144500041520841445000415
00841445000497008414450004978414450004970841445000497

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual underwearA garment intended to be worn directly against the skin, in the same manner as conventional women's underwear, to absorb menstrual blood or other vaginal discharge. It is typically constructed of cotton, lycra and/or polyester with a leak-proof thermoplastic polyurethane (TPU) barrier. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18664443482qaregulatory@divacup.com

Regulatory Flags#

DUNS number
207651758
Device count
1
Premarket exempt
true

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
00841445001111Diva Lubricator1FGBC2002012025-04-01
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
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
10850063931042Everylife Inc.EDEN FEMININE CARE LLCNUQ2025-06-02
10850063931059Everylife Inc. EDEN FEMININE CARE LLCNUQ2025-05-27
00850063931076Everylife Inc. EDEN FEMININE CARE LLCNUQ2025-05-27
00841445000428Diva UnderwearDiva International IncNUQ2024-07-17
00841445000435Diva UnderwearDiva International IncNUQ2024-07-17
00841445000442Diva UnderwearDiva International IncNUQ2024-07-17
00841445000459Diva UnderwearDiva International IncNUQ2024-07-17
00841445000466DivaDiva International IncNUQ2023-09-29
00841445000473DivaDiva International IncNUQ2023-09-29
00841445000480DivaDiva International IncNUQ2023-09-29
00850017666832LOLAALYK, INC.NUQ2022-07-08
00850017666870LOLAALYK, INC.NUQ2022-07-08
00850017666887LOLAALYK, INC.NUQ2022-07-08
00850017666849LOLAALYK, INC.NUQ2022-07-07
00850017666856LOLAALYK, INC.NUQ2022-07-07
00850017666863LOLAALYK, INC.NUQ2022-07-07