Duns Number:828222781
Device Description: VAPROX HC Sterilant is 59 percent Hydrogen Peroxide, designed specifically for use in the VAPROX HC Sterilant is 59 percent Hydrogen Peroxide, designed specifically for use in the V-PRO Low Temperature Sterilization Systems. The cup carries RFID tag. Net contents 3 -113 mL per cup.
Catalog Number
PB011
Brand Name
VAPROX
Version/Model Number
PB011
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K172754,K182568,K190103,K190917,K222093,K172754,K182568,K190103,K190917,K222093
Product Code
MLR
Product Code Name
Sterilizer, chemical
Public Device Record Key
b8010cdf-1327-4a5e-83c2-451b30d24a2e
Public Version Date
October 04, 2022
Public Version Number
4
DI Record Publish Date
August 23, 2018
Package DI Number
50724995153095
Quantity per Package
3
Contains DI Package
00724995153090
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 |