Duns Number:139424188
Device Description: Revital-Ox Resert High Level Disinfectant is a reusable high level disinfectant for proces 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.
Catalog Number
4455AW
Brand Name
Revital-Ox Resert
Version/Model Number
4455AW
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MED
Product Code Name
Sterilant, medical devices
Public Device Record Key
b42873a0-6069-4a48-bf28-308c9a52a6b2
Public Version Date
March 19, 2021
Public Version Number
8
DI Record Publish Date
September 07, 2016
Package DI Number
50724995095012
Quantity per Package
4
Contains DI Package
00724995095017
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |