Identity
- Trade Name
- Walgreens FDA UDI
- Generic Name
- Infrared-light cold sore treatment device FDA UDI
- Device Name
- Walgreens Reusable Cold Sore Treatment Device with Infrared Light Technology FDA UDI
- Model / Reference
- 845575 FDA UDI
- Description
- Walgreens Reusable Cold Sore Treatment Device with Infrared Light Technology FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00311917065007 FDA UDI
- 510(k) Number
- K222205 FDA UDI
- FDA Product Code
- OKJ FDA UDI
- GMDN Term
- Infrared-light cold sore treatment device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infrared-light cold sore treatment device
Walgreens by Walgreen Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Infrared-light cold sore treatment device.
- WALGREENS — WALGREEN CO. · Class II
Cleared under the same submission
K222205 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 |
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Manufacturer
- Manufacturer
- Walgreen Co.
Sources (1)
- FDA UDI 47ec0151-1d44-465a-a143-c5d9809f12e3 35 fields · synced May 30, 2026