Super Jennie
- Primary DI
- 00817453021168
- Brand
- Super Jennie
- Company
- Anigan Inc.
- Model
- Pink 2
- Catalog number
- SJ004
- Device description
- Super Jennie menstrual cup is a soft device made of medical grade silicone. It is to be placed by the user into the vagina to collect blood during menstruation.
- Published
- 2019-06-25
- 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
Related Records
Product 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 |
|---|---|---|---|---|
| 00817453021168 | Primary | GS1 | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Menstrual cup, non-latex, reusable | 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 made of a biocompatible synthetic material (e.g., silicone elastomer) and is normally available [non-prescription] over-the-counter (OTC). It is typically removed from the vagina by pulling on a protruding stem; depending upon design, it may or may not touch the cervix. The device can function as an alternative to tampons. This is a reusable device. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(999)999-9999 | askjennie@superjennie.com |
Regulatory Flags
- DUNS number
- 012179121
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00817453020437 | Super Jennie | Blue 2 | SJ005 | 2020-03-12 |
| 00817453020406 | Super Jennie | Teal 1 | SJ001 | 2019-06-25 |
| 00817453020413 | Super Jennie | Teal 2 | SJ002 | 2019-06-25 |
| 00817453020826 | EvaCup | Pink 1 | EVA001 | 2019-06-25 |
| 00817453020833 | EvaCup | Pink 2 | EVA002 | 2019-06-25 |
| 00817453021175 | Super Jennie | Pink 1 | SJ003 | 2019-06-25 |
| 00817453022035 | EvaCup | Cherry Blossom 1 | EVA003 | 2019-08-05 |
| 00817453022042 | EvaCup | Cherry Blossom 2 | EVA004 | 2019-08-05 |
| 08174530204060 | Super Jennie | Teal 1 | 2019-06-25 | |
| 08174530204138 | Super Jennie | Teal 2 | 2019-06-25 | |
| 08174530208266 | EvaCup | Pink 1 | 2019-06-25 | |
| 08174530208334 | EvaCup | Pink 2 | 2019-06-25 | |
| 08174530211686 | Super Jennie | Pink 2 | 2019-06-25 | |
| 08174530211754 | Super Jennie | Pink 1 | 2019-06-25 |
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