Duns Number:828222781
Device Description: The VAPROX HC Sterilant uses 59 percent Hydrogen Peroxide that is used with V-PRO Low Temp The VAPROX HC Sterilant uses 59 percent Hydrogen Peroxide that is used with V-PRO Low Temperature Sterilization Systems. The net contents are 29.6 mL per cup.
Catalog Number
PB028
Brand Name
VAPROX
Version/Model Number
PB028
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
K062297,K083097,K102330,K102394,K111810,K112760,K112813,K120632,K131120,K140498,K160433,K172319,K182568,K190103,K190917,K222093,K062297,K083097,K102330,K102394,K111810,K112760,K112813,K120632,K131120,K140498,K160433,K172319,K182568,K190103,K190917,K222093
Product Code
MLR
Product Code Name
Sterilizer, chemical
Public Device Record Key
0d2846a7-9817-4fec-bb56-862b6da48928
Public Version Date
October 04, 2022
Public Version Number
6
DI Record Publish Date
September 08, 2016
Package DI Number
10724995089518
Quantity per Package
4
Contains DI Package
00724995089511
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 |