Duns Number:605151018
Device Description: The Serim® GUARDIAN™ HiSENSE™ Test Kit indicates low levels of total chlorine (chloramine The Serim® GUARDIAN™ HiSENSE™ Test Kit indicates low levels of total chlorine (chloramine and/or free chlorine) in water used to prepare dialysate.
Catalog Number
5109
Brand Name
Serim® GUARDIAN™ HiSENSE™ Test Kit
Version/Model Number
5109
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
K952215,K952215,K952215
Product Code
FIP
Product Code Name
Subsystem, Water Purification
Public Device Record Key
478bd335-3a6a-471b-aaec-dba9f403ed61
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 19, 2016
Package DI Number
M17451092
Quantity per Package
5
Contains DI Package
M17451091
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kit