Duns Number:091381780
Device Description: Reagent test strip for measuring the concentration of residual chlorine (i.e. from chlorin Reagent test strip for measuring the concentration of residual chlorine (i.e. from chlorine bleach) in rinse water following disinfection of hemodialysis equipment.
Catalog Number
811900
Brand Name
SteriChek® Residual Chlorine Reagent Strips
Version/Model Number
811900
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K971598,K971598
Product Code
MSY
Product Code Name
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Public Device Record Key
972294f2-00d2-4c5b-b55c-419aef4028f5
Public Version Date
September 12, 2018
Public Version Number
4
DI Record Publish Date
November 23, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |