FDA UDI
In Commercial Distribution
🇺🇸 United States
Tampax
DI: 00073010715318
·
Model: Tampax Cup
·
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
Product Codes
1
GMDN Terms
1
Identifiers
6
Pkg Device Count
1
Basic Information
- Brand Name
- Tampax
- Primary DI
- 00073010715318
- Version / Model
- Tampax Cup
- Company Name
- PROCTER & GAMBLE MANUFACTURING COMPANY, THE
- Labeler DUNS
- 004238200
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-30
- Public Version
- 1
- Public Version Date
- 2021-09-07
- Public Version Status
- New
- Public Device Record Key
- 301fdbfc-1b6e-450e-8e75-dddf7215a12d
Device Description
Tampax Cup Heavy Flow
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
- 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
- Yes
- 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, 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 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10073010715377 | GS1 | case | 12 | In Commercial Distribution | |
| Primary | 00073010715318 | GS1 | ||||
| Package | 20073010715312 | GS1 | inner | 3 | In Commercial Distribution | |
| Package | 40073010715316 | GS1 | pallet | 112 | In Commercial Distribution | |
| Package | 10073010715315 | GS1 | case | 6 | In Commercial Distribution | |
| Package | 40073010715378 | GS1 | pallet | 48 | In Commercial Distribution |