Duns Number:605151018
Device Description: SERIM® GUARDIAN™ Peracetic Acid Test Strips indicate the concentration (potency) of perac SERIM® GUARDIAN™ Peracetic Acid Test Strips indicate the concentration (potency) of peracetic acid in dialyzer reprocessing concentrates such as Renalin® Cold Sterilant, PerAldecide™, Puristeril® 340, Peracidin™ and Micro-X®.
Catalog Number
5106
Brand Name
Serim® GUARDIAN™ Peracetic Acid Test Strips
Version/Model Number
5106
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
JOJ
Product Code Name
Indicator, Physical/Chemical Sterilization Process
Public Device Record Key
3dcb736e-b1a5-4059-9200-26fc94ce2725
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 08, 2016
Package DI Number
M17451062
Quantity per Package
6
Contains DI Package
M17451061
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kit