Identity
- Trade Name
- Vashe Wipes Skin Cleansing Solution Kit FDA UDI
- Generic Name
- Non-antimicrobial wound irrigation solution, multiple solute FDA UDI
- Device Name
- The Vashe Wipes Skin Cleansing Solution Kit contains a bottle of Vashe Wound Solution and dry, nonwoven wipes. The user is instructed to wet the wipes with the Solution just prior to use. The Kit is intended for use in cleansing patient skin. FDA UDI
- Model / Reference
- 00354 FDA UDI
- Description
- The Vashe Wipes Skin Cleansing Solution Kit contains a bottle of Vashe Wound Solution and dry, nonwoven wipes. The user is instructed to wet the wipes with the Solution just prior to use. The Kit is intended for use in cleansing patient skin. FDA UDI
Identifiers
- Catalog Number
- 00354 FDA UDI
- Primary DI / UDI-DI
- 00190769003548 FDA UDI
- FDA Product Code
- MAC FDA UDI
- GMDN Term
- Non-antimicrobial wound irrigation solution, multiple solute FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4014 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Vashe Wipes Skin Cleansing Solution Kit by Urgo Medical North America, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Urgo Medical North America, LLC
Sources (1)
- FDA UDI 6f4949e7-a450-4ee9-88f7-8dc2ce423726 37 fields · synced Jun 9, 2026