Flex
- Primary DI
- 10850037498151
- Brand
- Flex
- Company
- The Flex Company
- Model
- Box of Flex Disc 8 ct.
- Device description
- Box of Flex Disc 8 count Box
- Published
- 2022-09-29
- 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
Related Records
Contact Domains
flexfits.comProduct Codes
| Code | Name |
|---|---|
| HHE | Cup, Menstrual |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| HHE | Cup, Menstrual | Obstetrics/Gynecology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10850037498151 | Package | GS1 | 3 | In Commercial Distribution |
| 20850037498158 | Package | GS1 | 6 | In Commercial Distribution |
| 00850037498154 | Primary | GS1 | 0 | |
| 00851906007040 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10850037498151 | 10850037498151 | ||
| 20850037498158 | 20850037498158 | ||
| 00850037498154 | 00850037498154 | 850037498154 | 0850037498154 |
| 00851906007040 | 00851906007040 | 851906007040 | 0851906007040 |
GMDN Terms
| Term | Definition |
|---|---|
| Menstrual cup, non-latex, single-use | A 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 |
|---|
Contacts
| Phone | |
|---|---|
| 18009310882 | hello@flexfits.com |
Regulatory Flags
- DUNS number
- 080314616
- Device count
- 8
- 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 | Catalog | Published |
|---|---|---|---|---|
| 10850037498427 | Flex | 10268 | 2025-06-12 | |
| 10850037498144 | Flex | 10035 | 2023-01-06 | |
| 20851906007716 | Flex | 10150 | 2022-09-06 | |
| 10851906007023 | Softdisc | Box of Softdisc 14 count (English/French for Canad | 2022-07-21 | |
| 00851906007040 | Flex Disc | 10018 | 2022-03-14 | |
| 00851906007620 | Flex Plant+ Menstrual Disc | 10128 | 2022-01-19 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00860012792801 | Lunable | Yayoi FemTech Inc. | HHE | 2025-09-02 |
| 00841445001326 | DivaCup Impact | Diva International Inc | HHE | 2025-09-01 |
| 00841445001333 | DivaCup Impact | Diva International Inc | HHE | 2025-09-01 |
| 00841445001340 | DivaCup Impact | Diva International Inc | HHE | 2025-09-01 |
| 00850068130221 | Pixie Cup | Pixie Cup LLC | HHE | 2025-08-02 |
| 00860417001393 | Pixie Cup | Pixie Cup LLC | HHE | 2025-06-26 |
| 00869352000348 | Pixie Cup | Pixie Cup LLC | HHE | 2025-06-26 |
| 00715875074840 | Pixie Cup | Pixie Cup LLC | HHE | 2025-06-25 |
| 00850016867742 | Pixie Cup | Pixie Cup LLC | HHE | 2025-06-25 |
| 00860013832001 | Selaviera Cup | CASCO BAY MOLDING LTD. | HHE | 2025-06-18 |
| 00860013832018 | Selaviera Cup | CASCO BAY MOLDING LTD. | HHE | 2025-06-18 |
| 00860013832025 | Selaviera Cup | CASCO BAY MOLDING LTD. | HHE | 2025-06-18 |
| 10850037498427 | Flex | The Flex Company | HHE | 2025-06-12 |
| 09421907199696 | Hello Period | THE HELLO CUP COMPANY LIMITED | HHE | 2025-06-10 |
| 07898976999007 | Mestrual disc clear Small | INJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDA | HHE | 2025-06-09 |
| 07898976999014 | Mestrual disc clear Medium | INJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDA | HHE | 2025-06-09 |
| 07898976999021 | Mestrual disc clear High | INJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDA | HHE | 2025-06-09 |
| 07898976999038 | Mestrual disc Pink Love Small | INJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDA | HHE | 2025-06-09 |
| 07898976999045 | Mestrual disc Pink Love Medium | INJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDA | HHE | 2025-06-09 |
| 07898976999052 | Mestrual disc Pink Love High | INJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDA | HHE | 2025-06-09 |
| 07898976999069 | Mestrual disc Unicorn Small | INJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDA | HHE | 2025-06-09 |
| 07898976999076 | Mestrual disc Unicorn Medium | INJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDA | HHE | 2025-06-09 |
| 07898976999083 | Mestrual disc Unicorn High | INJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDA | HHE | 2025-06-09 |
| 07898976999090 | Mestrual cup Pink Love Small | INJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDA | HHE | 2025-06-09 |
| 07898976999106 | Mestrual cup Pink Love Medium | INJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDA | HHE | 2025-06-09 |
| 07898976999113 | Mestrual cup Pink Love High | INJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDA | HHE | 2025-06-09 |
| 00311917057415 | Walgreens | WALGREEN CO. | HHE | 2025-05-16 |
| 00311917057446 | Walgreens | WALGREEN CO. | HHE | 2025-05-16 |
| 00850066493052 | Casco Cup | CASCO BAY MOLDING LTD. | HHE | 2025-02-07 |
| 09420060212013 | SensiCup - Frosted - 20ml - 1pc | THINK GREEN LIMITED | HHE | 2024-12-17 |