Duns Number:605151018
Device Description: Serim® GUARDIAN™ RESIDUAL CHLORINE Test Strips indicate the concentration of chlorine blea Serim® GUARDIAN™ RESIDUAL CHLORINE Test Strips indicate the concentration of chlorine bleach (sodium hypochlorite) remaining in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment.
Catalog Number
5100A
Brand Name
Serim® GUARDIAN™ Residual Chlorine Test Strips
Version/Model Number
5100A
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
-
Product Code
FKJ
Product Code Name
Filter, Blood, Dialysis
Public Device Record Key
2e53b621-681f-490b-b927-1654ccbd2523
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 29, 2016
Package DI Number
M1745100A2
Quantity per Package
6
Contains DI Package
M1745100A1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kit