The DivaCup DV010
GUDID 00857538000145
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.
Diva International Inc
Menstrual cup, non-latex, reusable| Primary Device ID | 00857538000145 |
| NIH Device Record Key | 606b6b20-e408-4ccb-ae4f-d21e0afbacfc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | The DivaCup |
| Version Model Number | Model B PL |
| Catalog Number | DV010 |
| Company DUNS | 207651758 |
| Company Name | Diva International Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857538000145 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K021356
FDA Product Code
| HHE | Cup, Menstrual |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-09 |
| Device Publish Date | 2018-02-23 |
On-Brand Devices [The DivaCup]
| 00857538000244 | Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the use |
| 00857538000237 | Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the use |
| 00857538000169 | Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the use |
| 00857538000152 | Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the use |
| 00857538000145 | Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the use |
| 00857538000138 | Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the use |
| 10857538000043 | Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the use |
| 10857538000258 | Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the use |
| 00050428645888 | Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the use |
| 00050428645598 | Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the use |
Trademark Results [The DivaCup]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THE DIVACUP 86454785 4768469 Live/Registered |
Diva International Inc. 2014-11-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.