Duns Number:218172765
Device Description: The VERIFY HPU Chemical Indicator is a vaporized hydrogen peroxide sterilization process i The VERIFY HPU Chemical Indicator is a vaporized hydrogen peroxide sterilization process indicator designed for use in the V-PRO Low Temperature Sterilization Systems.
Catalog Number
PCC061
Brand Name
VERIFY
Version/Model Number
PCC061
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
f5cfdd78-043b-4845-b921-fe944ee8358a
Public Version Date
February 19, 2021
Public Version Number
8
DI Record Publish Date
September 06, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |