Duns Number:218172765
Device Description: The VERIFY Process Indicator for the Reliance EPS Endoscope Processing System is a peracet The VERIFY Process Indicator for the Reliance EPS Endoscope Processing System is a peracetic acid concentration indicator that changes color to the ENDPOINT reference block upon exposure to an effective dose of peracetic acid. It is intended for use for routine monitoring of the Reliance EPS Endoscope Processing System employing Reliance DG Dry Germicide.
Catalog Number
PCC029
Brand Name
VERIFY
Version/Model Number
PCC029
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
4f734884-0597-4272-99e1-54a053f7145c
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
May 29, 2020
Package DI Number
50724995172195
Quantity per Package
2
Contains DI Package
10724995172197
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 |