Identity
- Trade Name
- Revital-Ox FDA UDI
- Generic Name
- Medical device disinfection agent FDA UDI
- Device Name
- Revital-Ox PAA HLD Solution Part B is used Revital-Ox PAA HLD Part A and the enspire 300 Series Automated Endoscope Reprocessor FDA UDI
- Model / Reference
- 4454AW FDA UDI
- Description
- Revital-Ox PAA HLD Solution Part B is used Revital-Ox PAA HLD Part A and the enspire 300 Series Automated Endoscope Reprocessor FDA UDI
Identifiers
- Catalog Number
- 4454AW FDA UDI
- Primary DI / UDI-DI
- 00724995216900 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical device disinfection agent
Revital-Ox by Steris Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K230560 also covers:
K232918 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
- Steris Corporation
Sources (1)
- FDA UDI 228dad3b-a85b-43f0-9627-9259052aad71 36 fields · synced Jun 8, 2026