Identity
- Trade Name
- Revital-Ox Resert FDA UDI
- Generic Name
- Medical device disinfection agent FDA UDI
- Device Name
- Revital-Ox Resert High Level Disinfectant is a reusable high level disinfectant for processing semi-critical medical devices for which alternative methods of terminal processing are not suitable or available. It is for use in both manual soaking and automated endoscope processors. It must be used with Revital-Ox RESERT R60 Solution Test Strips. FDA UDI
- Model / Reference
- 4455AW FDA UDI
- Description
- Revital-Ox Resert High Level Disinfectant is a reusable high level disinfectant for processing semi-critical medical devices for which alternative methods of terminal processing are not suitable or available. It is for use in both manual soaking and automated endoscope processors. It must be used with Revital-Ox RESERT R60 Solution Test Strips. FDA UDI
Identifiers
- Catalog Number
- 4455AW FDA UDI
- Primary DI / UDI-DI
- 00724995095017 FDA UDI
- FDA Product Code
- MED FDA UDI
- GMDN Term
- Medical device disinfection agent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6885 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 4 Liter FDA UDI
Category: Medical device disinfection agent
Revital-Ox Resert by Steris Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Steris Corporation
Sources (1)
- FDA UDI b42873a0-6069-4a48-bf28-308c9a52a6b2 37 fields · synced Jun 8, 2026