FDA.reportPublic FDA data

The DivaCup

Primary DI
10857538000258
Brand
The DivaCup
Company
Diva International Inc
Model
Model 1
Catalog number
DV001
Device description
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Published
2017-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHECup, Menstrual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHECup, MenstrualObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021356000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021356000THE DIVACUP MENSTRUAL SOLUTIONDiva International, Inc.2002-07-16HHE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841445000296PackageGS14In Commercial Distribution
10857538000036PackageGS160In Commercial Distribution
10857538000074PackageGS16In Commercial Distribution
10857538000258PackageGS14In Commercial Distribution
20841445000279PackageGS124In Commercial Distribution
00857538000015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084144500029610841445000296
1085753800003610857538000036
1085753800007410857538000074
1085753800025810857538000258
2084144500027920841445000279
00857538000015008575380000158575380000150857538000015

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual cup, non-latex, reusableA cup-like receptacle placed by the user into the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. It is a small, soft device made of a biocompatible synthetic material (e.g., silicone elastomer) and is normally available [non-prescription] over-the-counter (OTC). It is typically removed from the vagina by pulling on a protruding stem; depending upon design, it may or may not touch the cervix. The device can function as an alternative to tampons. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5198968100roxanne@divacup.com
8664443482ISORegulatory@divacup.com
8664443482qaregulatory@divacup.com

Regulatory Flags#

DUNS number
207651758
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00841445000497Diva3XL-4XLFGUN060201BK042023-09-29
00841445001678Diva Disc1FGCU0501012023-04-27
00857538000237The DivaCupModel 0FGCU0001012018-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428087701The DivaCupDiva International IncHHE2026-03-31
00050428088852The DivaCupDiva International IncHHE2026-03-31
00850037498390FlexThe Flex CompanyHHE2025-11-05
00860012792801LunableYayoi FemTech Inc.HHE2025-09-02
00841445001326DivaCup ImpactDiva International IncHHE2025-09-01
00841445001333DivaCup ImpactDiva International IncHHE2025-09-01
00841445001340DivaCup ImpactDiva International IncHHE2025-09-01
00850068130221Pixie CupPixie Cup LLCHHE2025-08-02
00860417001393Pixie CupPixie Cup LLCHHE2025-06-26
00869352000348Pixie CupPixie Cup LLCHHE2025-06-26
00715875074840Pixie CupPixie Cup LLCHHE2025-06-25
00850016867742Pixie CupPixie Cup LLCHHE2025-06-25
00850016867780Pixie CupPixie Cup LLCHHE2025-06-24
00860013832001Selaviera CupCASCO BAY MOLDING LTD.HHE2025-06-18
00860013832018Selaviera CupCASCO BAY MOLDING LTD.HHE2025-06-18
00860013832025Selaviera CupCASCO BAY MOLDING LTD.HHE2025-06-18
00850037498420FlexThe Flex CompanyHHE2025-06-12
10850037498427FlexThe Flex CompanyHHE2025-06-12
09421907199696Hello PeriodTHE HELLO CUP COMPANY LIMITEDHHE2025-06-10
07898976999007Mestrual disc clear SmallINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999014Mestrual disc clear MediumINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999021Mestrual disc clear HighINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999038Mestrual disc Pink Love SmallINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999045Mestrual disc Pink Love MediumINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999052Mestrual disc Pink Love HighINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999069Mestrual disc Unicorn SmallINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999076Mestrual disc Unicorn MediumINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999083Mestrual disc Unicorn HighINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999090Mestrual cup Pink Love SmallINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999106Mestrual cup Pink Love MediumINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09