Duns Number:605151018
Device Description: SERIM GUARDIAN HiSENSE ULTRA 0.1 Test Strips indicates low levels of total chlorine (chlor SERIM GUARDIAN HiSENSE ULTRA 0.1 Test Strips indicates low levels of total chlorine (chloramines/free chlorine) in feed water used to prepare dialysate. The test also indicates the concentration of residual chlorine (chlorine bleach) remaining in the water used to rinse dialysate lines following disinfection of hemodialysis equipment.
Catalog Number
5167
Brand Name
Serim® GUARDIAN™ HiSENSE ULTRA 0.1™ Test Strips
Version/Model Number
5167
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
K080712,K080712,K080712,K080712
Product Code
MSY
Product Code Name
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Public Device Record Key
23f45c46-bd24-4f5b-a625-6b35427eebeb
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 08, 2016
Package DI Number
M1745167IN2
Quantity per Package
1
Contains DI Package
M17451671
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kit