FDA UDI
In Commercial Distribution
🇺🇸 United States
H-E-B
DI: 00041220410279
·
Model: 100% Cotton Tampons Multipack
·
H. E. BUTT GROCERY COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- H-E-B
- Primary DI
- 00041220410279
- Version / Model
- 100% Cotton Tampons Multipack
- Catalog Number
- 679686
- Company Name
- H. E. BUTT GROCERY COMPANY
- Labeler DUNS
- 007924756
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-31
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 31d47fa4-59be-49b6-9607-140f98a6496a
Device Description
The device will be offered as a traditional unscented menstrual 100% cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The box contains two types of tampons (12+12) offered in two absorbencies: Regular and Super. Each tampon is registered in GUDID database with a different Primary DI Number: - 100% Cotton Tampons Regular: 00041220410224 - 100% Cotton Tampons Super: 00041220410262
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | Obstetrics/Gynecology | 884.5470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35694 | Menstrual tampon, unscented | A non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual blood or other vaginal discharge. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30041220410270 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 00041220410279 | GS1 |
Customer Contacts
- Phone
- +1(718)7277455
- [email protected]