Duns Number:605151018
Device Description: Serim® GUARDIAN™ Residual Peroxide Test Strips measure the concentration of peroxide remai Serim® GUARDIAN™ Residual Peroxide Test Strips measure the concentration of peroxide remaining in dialysate lines and dialyzers after disinfection with peracetic acid/peroxide-based disinfectants.
Catalog Number
5105
Brand Name
Serim® GUARDIAN™ Residual Peroxide Test Strips
Version/Model Number
5105
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K900341,K900341,K900341
Product Code
LIF
Product Code Name
Dialyzer Reprocessing System
Public Device Record Key
eed295b2-2308-4e43-a214-3282aacd7e28
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 08, 2016
Package DI Number
M17451052
Quantity per Package
6
Contains DI Package
M17451051
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kit