Identity
- Trade Name
- CareOne FDA UDI
- Generic Name
- Non-antimicrobial wound irrigation solution, multiple solute FDA UDI
- Device Name
- Wound Wash, 8 FL OZ (240 mL) FDA UDI
- Model / Reference
- 341520877889 FDA UDI
- Description
- Wound Wash, 8 FL OZ (240 mL) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00341520877889 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Non-antimicrobial wound irrigation solution, multiple solute FDA UDI
Classification
- Device Class
- U 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-antimicrobial wound irrigation solution, multiple solute
CareOne by Ahold U.S.A., Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-antimicrobial wound irrigation solution, multiple solute.
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- McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
- Renovar Advanced — H R Pharmaceuticals, Inc. · U
- Hydrocleanse Wound Care Solution — Sonoma Pharmaceuticals, Inc. · U
- PrimaDerm® — Derma Sciences Canada, Inc · U
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 U | Pending data |
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Manufacturer
- Manufacturer
- Ahold U.S.A., Inc.
Sources (1)
- FDA UDI a352fbb3-5d31-4657-a5e3-fb11f2907a6b 33 fields · synced May 30, 2026