FDA UDI
In Commercial Distribution
🇺🇸 United States
CareOne Tampons
DI: 00041520039934
·
Model: CA11812SO/1
·
Ahold U.S.A., Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
18
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- CareOne Tampons
- Primary DI
- 00041520039934
- Version / Model
- CA11812SO/1
- Company Name
- Ahold U.S.A., Inc.
- Labeler DUNS
- 170199058
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 18
- Record Status
- Published
- Publish Date
- 2016-09-08
- Public Version
- 5
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 4eab582a-f246-41fb-aad1-13259b6aa694
Device Description
SCENTED REGULAR PLASTIC APPLICATOR TAMPONS
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- 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 |
|---|---|---|---|---|
| HIL | Tampon, Menstrual, Scented, Deodorized | Obstetrics/Gynecology | 884.5460 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32683 | Menstrual tampon, scented | A 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 | 10041520039931 | GS1 | CASE | 12 | In Commercial Distribution | |
| Primary | 00041520039934 | GS1 | ||||
| Unit of Use | 00004152003995 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K050067 | 000 |