Duns Number:605151018
Device Description: Serim® GUARDIAN™ Residual Formaldehyde Test Strips measure the concentration of formaldeh Serim® GUARDIAN™ Residual Formaldehyde Test Strips measure the concentration of formaldehyde remaining after rinsing dialyzers or dialysate lines prior to use in hemodialysis.
Catalog Number
5112
Brand Name
Serim® GUARDIAN™ Residual Formaldehyde Test Strips
Version/Model Number
5112
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
K914123,K914123
Product Code
LIF
Product Code Name
Dialyzer Reprocessing System
Public Device Record Key
0498db39-1802-49e3-a0c9-7db0e58b5f61
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 08, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-