Duns Number:218172765
Device Description: The Revital-Ox Resert R60 Solution Test Strip is a chemical indicator designed exclusively The Revital-Ox Resert R60 Solution Test Strip is a chemical indicator designed exclusively for monitoring of Revital-Ox RESERT High Level Solutions.
Catalog Number
PCC054
Brand Name
Revital-Ox Resert
Version/Model Number
PCC054
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
Yes
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
JOJ
Product Code Name
Indicator, physical/chemical sterilization process
Public Device Record Key
43dd3065-7838-412f-a8c7-d9668eeb8279
Public Version Date
October 28, 2020
Public Version Number
3
DI Record Publish Date
May 29, 2020
Package DI Number
50724995172218
Quantity per Package
2
Contains DI Package
10724995172210
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |