Duns Number:091381780
Device Description: Reagent test strips used to measure the concentration of residual peroxide in rinse water Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines disinfected with peroxide/peracetic acid.
Catalog Number
811905B
Brand Name
Stericide Peroxide Reagent Strips
Version/Model Number
811905B
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K974798
Product Code
LIF
Product Code Name
Dialyzer Reprocessing System
Public Device Record Key
0cdd718c-f823-4150-83b7-44cc9f648c4e
Public Version Date
April 22, 2020
Public Version Number
1
DI Record Publish Date
April 14, 2020
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. | 10 |