FDA.reportPublic FDA data

Flex Disc

Primary DI
00851906007040
Brand
Flex Disc
Company
The Flex Company
Model
10018
Device description
Flex Disc 24ct Vertical Bag
Published
2022-03-14
Public version status
New
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
10850037498007PackageGS13In Commercial Distribution
10850037498137PackageGS110In Commercial Distribution
20850037498004PackageGS12In Commercial Distribution
20850037498417PackageGS13In Commercial Distribution
30850037498414PackageGS13In Commercial Distribution
00850037498000PrimaryGS10
00850037498130PrimaryGS10
00850037498413PrimaryGS10
00851906007040Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003749800710850037498007
1085003749813710850037498137
2085003749800420850037498004
2085003749841720850037498417
3085003749841430850037498414
00850037498000008500374980008500374980000850037498000
00850037498130008500374981308500374981300850037498130
00850037498413008500374984138500374984130850037498413
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
800-931-0882hello@flexfits.com
18009310882hello@flexfits.com
18009310882help@flexfits.com

Regulatory Flags#

DUNS number
080314616
Device count
24
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
10850037498427Flex102682025-06-12
10850037498144Flex100352023-01-06
10850037498151FlexBox of Flex Disc 8 ct. 2022-09-29
20851906007716Flex101502022-09-06
10851906007023SoftdiscBox of Softdisc 14 count (English/French for Canad2022-07-21
00851906007620Flex Plant+ Menstrual Disc101282022-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00860013832001Selaviera CupCASCO BAY MOLDING LTD.HHE2025-06-18
00860013832018Selaviera CupCASCO BAY MOLDING LTD.HHE2025-06-18
00860013832025Selaviera CupCASCO BAY MOLDING LTD.HHE2025-06-18
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
07898976999113Mestrual cup Pink Love HighINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
00311917057415WalgreensWALGREEN CO.HHE2025-05-16
00311917057446WalgreensWALGREEN CO.HHE2025-05-16
00850066493052Casco CupCASCO BAY MOLDING LTD.HHE2025-02-07
09420060212013SensiCup - Frosted - 20ml - 1pcTHINK GREEN LIMITEDHHE2024-12-17