FDA.reportPublic FDA data

Flex

Primary DI
10850037498144
Brand
Flex
Company
The Flex Company
Model
10035
Device description
Flex Disc 16ct Bag
Published
2023-01-06
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850037498144PackageGS16In Commercial Distribution
00850037498147PrimaryGS10
00851906007040Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003749814410850037498144
00850037498147008500374981478500374981470850037498147
00851906007040008519060070408519060070400851906007040

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual cup, non-latex, single-useA 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 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 or by insertion of a finger to catch its rim; depending upon design, it may or may not touch the cervix. The device can function as an alternative to tampons and may remain in situ during sexual intercourse. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18009310882hello@flexfits.com

Regulatory Flags#

DUNS number
080314616
Device count
16
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

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
00851906007712Flex101502022-09-06
00851906007729Softdisc101192022-11-30

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