FDA UDI
In Commercial Distribution
🇺🇸 United States
Kind Cup
DI: G357DV0
·
Model: Duo Violet
·
Wevotopia LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
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Basic Information
- Brand Name
- Kind Cup
- Primary DI
- G357DV0
- Version / Model
- Duo Violet
- Catalog Number
- DV
- Company Name
- Wevotopia LLC
- Labeler DUNS
- 122319040
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2022-11-22
- Public Version
- 2
- Public Version Date
- 2025-07-14
- Public Version Status
- Update
- Public Device Record Key
- 0de855af-49ca-424a-976e-6109cef49feb
Device Description
Duo Pack Violet of one size small and one size regular menstrual cups with violet pigment.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HHE | Cup, Menstrual | Obstetrics/Gynecology | 884.5400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47728 | Menstrual cup/disc, non-latex, reusable | A cup-like or disc-shaped 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 typically removed from the vagina by pulling on a protruding stem/ring or by insertion of a finger to catch its rim. The device can function as an alternative to tampons and may remain in situ during sexual intercourse. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G357DV0 | HIBCC | ||||
| Unit of Use | G357DV1 | HIBCC |