Identity
- Trade Name
- Bpure FDA UDI
- Generic Name
- Menstrual tampon, unscented FDA UDI
- Device Name
- BPURE ORGANIC REGULAR TAMPONS 18CT FDA UDI
- Model / Reference
- 64431638E FDA UDI
- Description
- BPURE ORGANIC REGULAR TAMPONS 18CT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00049696608107 FDA UDI
- 510(k) Number
- K231341 FDA UDI
- FDA Product Code
- HEB FDA UDI
- GMDN Term
- Menstrual tampon, unscented FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5470 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Menstrual tampon, unscented
Bpure by Fourstar Group Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Menstrual tampon, unscented.
- Shopko Tampons — Shopko · Class II
- Tampax — PROCTER & GAMBLE MANUFACTURING COMPANY, THE · Class II
- Exchange Select Tampons — Aafes · Class II
- Tampax — PROCTER & GAMBLE MANUFACTURING COMPANY, THE · Class II
- Shopko Tampons — Shopko · Class II
- Tampax — PROCTER & GAMBLE MANUFACTURING COMPANY, THE · Class II
- Family Wellness — Family Dollar Stores · Class II
- Tampax — PROCTER & GAMBLE MANUFACTURING COMPANY, THE · Class II
Cleared under the same submission
K231341 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fourstar Group Inc.
Sources (1)
- FDA UDI 84703476-1dfc-46f1-974a-c468c52638f0 34 fields · synced May 30, 2026