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AlphaCleanse® Antimicrobial Wound Care System
FDA UDIClass II (US FDA UDI)
by Bionix, LLC
Identity
- Trade Name
- AlphaCleanse® Antimicrobial Wound Care System FDA UDI
- Generic Name
- Wound irrigation kit FDA UDI
- Device Name
- AlphaCleanse® Antimicrobial Wound Care System FDA UDI
- Model / Reference
- WI-5750 FDA UDI
- Description
- AlphaCleanse® Antimicrobial Wound Care System FDA UDI
Identifiers
- Catalog Number
- 5750 FDA UDI
- Primary DI / UDI-DI
- 00714646000804 FDA UDI
- FDA Product Code
- FQH FDA UDI
- GMDN Term
- Wound irrigation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5475 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radiation Sterilization FDA UDI
AlphaCleanse® Antimicrobial Wound Care System by Bionix, LLC — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Bionix, LLC
Sources (1)
- FDA UDI b12e2884-eb0b-47f2-8d7c-28e19af1808b 36 fields · synced May 30, 2026