FDA.reportPublic FDA data

Flex

Primary DI
00851906007712
Brand
Flex
Company
The Flex Company
Model
10150
Device description
Flex Disc 24 count Horizontal Bag
Published
2022-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHECup, Menstrual

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20851906007716PackageGS13In Commercial Distribution
30851906007713PackageGS12In Commercial Distribution
00851906007712PrimaryGS10
00851906007040Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085190600771620851906007716
3085190600771330851906007713
00851906007712008519060077128519060077120851906007712
00851906007040008519060070408519060070400851906007040

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual cup/disc, non-latex, single-useA cup-like or disc-shaped 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 typically made of a biocompatible synthetic materials (e.g., low density polyethylene) and is typically removed from the vagina by pulling on a protruding stem/ring or by insertion of a finger to catch its rim. The device can function as an alternative to tampons and may remain in situ during sexual intercourse. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
18009310882hello@flexfits.com

Regulatory Flags#

DUNS number
080314616
Device count
24
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850037498390Flex102552025-11-05
20851906007006SoftdiscSoftdisc Bulk Case of 13712022-09-29
00850037498000Flex Disc100182022-03-14
00850037498130Flex100172023-01-06
00850037498147Flex100352023-01-06
00850037498154FlexBox of Flex Disc 8 ct. 2022-09-29
00850037498413Flex102602025-01-28
00850037498420Flex102682025-06-12
00851906007026SoftdiscBox of Softdisc 14 count (English/French for Canad2022-07-21
00851906007088FlexFlex 24 count bag (English only)2018-06-20
00851906007156FlexFlex 16 count bag (English only)2018-08-30
00851906007200Flex CupSingle Flex Cup Full Fit (Size 2) box2019-04-15
00851906007262Flex Cup and Flex DiscFlex Discovery Kit Slim Fit2019-03-14
00851906007439Softcup100892021-10-27
00851906007453Softcup100902021-10-27
00851906007477SoftdiscSoftdisc 5 count bag (English only)2021-03-22
00851906007552FlexFlex Disc 102 (IHUT)2021-05-05
00851906007576FlexFlex Chamfer Disc 101 (IHUT)2021-05-05
00851906007729Softdisc101192022-11-30
00851906007620Flex Plant+ Menstrual Disc101282022-01-19

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