Identity
- Trade Name
- Revital-Ox FDA UDI
- Generic Name
- Medical device disinfection solution test strip FDA UDI
- Device Name
- The Revital-Ox PAA High Level Disinfectant Chemical Indicator is used for the routine monitoring of enspire 300 Series Automated Endoscope Reprocessor employing Revital-Ox PAA High Level Disinfectant. FDA UDI
- Model / Reference
- PCC081 FDA UDI
- Description
- The Revital-Ox PAA High Level Disinfectant Chemical Indicator is used for the routine monitoring of enspire 300 Series Automated Endoscope Reprocessor employing Revital-Ox PAA High Level Disinfectant. FDA UDI
Identifiers
- Catalog Number
- PCC081 FDA UDI
- Primary DI / UDI-DI
- 10724995217362 FDA UDI
- 510(k) Number
- K230558 FDA UDI
- FDA Product Code
- JOJ FDA UDI
- GMDN Term
- Medical device disinfection solution test strip FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2800 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical device disinfection solution test strip
Revital-Ox by Albert Browne , Ltd. — 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
- Albert Browne , Ltd.
Sources (1)
- FDA UDI e49d7131-84bd-4731-9a94-eb2e69d1a244 37 fields · synced May 30, 2026