FDA UDI
In Commercial Distribution
🇺🇸 United States
EvaCup
DI: 00817453020833
·
Model: Pink 2
·
Anigan Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EvaCup
- Primary DI
- 00817453020833
- Version / Model
- Pink 2
- Catalog Number
- EVA002
- Company Name
- Anigan Inc.
- Labeler DUNS
- 012179121
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-25
- Public Version
- 4
- Public Version Date
- 2025-07-14
- Public Version Status
- Update
- Public Device Record Key
- b4c75358-cd8c-465c-82ea-256c7a6f5e64
Device Description
EvaCup 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- 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
- Yes
- 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
- No
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 | 00817453020833 | GS1 |
Customer Contacts
- Phone
- +1(999)999-9999
- [email protected]