Identity
- Trade Name
- CareOne Tampons FDA UDI
- Generic Name
- Menstrual tampon, scented FDA UDI
- Device Name
- SCENTED REGULAR PLASTIC APPLICATOR TAMPONS FDA UDI
- Model / Reference
- CA11812SO/1 FDA UDI
- Description
- SCENTED REGULAR PLASTIC APPLICATOR TAMPONS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00041520039934 FDA UDI
- 510(k) Number
- K050067 FDA UDI
- FDA Product Code
- HIL FDA UDI
- GMDN Term
- Menstrual tampon, scented FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5460 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Menstrual tampon, scented
CareOne Tampons by Ahold U.S.A., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Menstrual tampon, scented.
- SMART SENSE Tampons — KMART HOLDING CORPORATION · Class II
- Smart Sense Tampons — KMART HOLDING CORPORATION · Class II
- CVS Health Tampons — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · Class II
- H-E-B Tampons — H. E. BUTT GROCERY COMPANY · Class II
- Tampax — PROCTER & GAMBLE MANUFACTURING COMPANY, THE · Class II
- Playtex — EDGEWELL PERSONAL CARE BRANDS, LLC · Class II
- Playtex — EDGEWELL PERSONAL CARE BRANDS, LLC · Class II
- Tampax — PROCTER & GAMBLE MANUFACTURING COMPANY, THE · Class II
Cleared under the same submission
K050067 also covers:
- DG Health Tampons — DOLGENCORP, LLC
- DG Health Tampons — DOLGENCORP, LLC
- FRED'S TAMPONS — FRED'S, INC.
- FRED'S TAMPONS — FRED'S, INC.
- FEMTEX — First Quality Hygienic, Inc.
- FEMTEX — First Quality Hygienic, Inc.
- MEIJER TAMPONS — MEIJER, INC.
- MEIJER TAMPONS — MEIJER, INC.
- CVS HEALTH TAMPONS — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- CVS HEALTH TAMPONS — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- CVS HEALTH TAMPONS — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ahold U.S.A., Inc.
Sources (1)
- FDA UDI 4eab582a-f246-41fb-aad1-13259b6aa694 34 fields · synced May 30, 2026