FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Keela Cup
DI: 00851906007231
·
Model: Keela Cup Full Fit Size B
·
The Flex Company
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Keela Cup
- Primary DI
- 00851906007231
- Version / Model
- Keela Cup Full Fit Size B
- Company Name
- The Flex Company
- Labeler DUNS
- 080314616
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-15
- Public Version
- 4
- Public Version Date
- 2022-01-26
- Public Version Status
- Update
- Public Device Record Key
- c1aea8fd-2b35-4a64-8ed6-b056b0508a0d
- Distribution End Date
- 2021-03-05
Device Description
Keela Cup Full Fit Size B (English only)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 47723 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851906007231 | GS1 |
Customer Contacts
- Phone
- 15103942467
- [email protected]