Duns Number:256900895
Device Description: The 125-280 Solution™ product is 50% liquid hydrogen peroxide solution (CAS# 7722-84-1) pr The 125-280 Solution™ product is 50% liquid hydrogen peroxide solution (CAS# 7722-84-1) provided in 280 mL bottles. The active ingredient is 50% H2O2 by weight and the inactive ingredients are water and stabilizing agents. The 125-280 Solution™ product is a stabilized analytical grade. The 125-280 Solution™ product is supplied in a bottle specially designed for use only in the STERIZONE® VP4 Sterilizer
Catalog Number
44010
Brand Name
125-280 Solution™ for STERIZONE VP4 Sterilizer
Version/Model Number
44010
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
K153392,K153392
Product Code
PJJ
Product Code Name
Two Or More Sterilant Sterilizer
Public Device Record Key
44f8331f-6173-47bc-b6ee-3d4c0c005e7b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 14, 2016
Package DI Number
00690455045604
Quantity per Package
4
Contains DI Package
00690455440102
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |