Duns Number:605151018
Device Description: Serim® GUARDIAN™ Bicarb pH II Test Strips are designed to test bicarbonate concentrate and Serim® GUARDIAN™ Bicarb pH II Test Strips are designed to test bicarbonate concentrate and/or final dialysate solutions for the appropriate pH where bicarbonate and acid and water are mixed in closed systems.
Catalog Number
5116A
Brand Name
Serim® GUARDIAN™ Bicarb pH II Test Strips
Version/Model Number
5116A
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
K945491,K945491,K945491
Product Code
MNV
Product Code Name
Strip, Dialysate Ph Indicator
Public Device Record Key
f281f04b-6472-4e0e-8e69-c3856cea7091
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 19, 2016
Package DI Number
M1745116A2
Quantity per Package
5
Contains DI Package
M1745116A1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kit