Duns Number:091381780
Device Description: Reagent test kit used to measure low levels of total chlorine in feed water used to prepar Reagent test kit used to measure low levels of total chlorine in feed water used to prepare dialysate.
Catalog Number
811902
Brand Name
SteriChek® Total Chlorine Test Kit
Version/Model Number
811902
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
K983997,K983997
Product Code
FIP
Product Code Name
Subsystem, Water Purification
Public Device Record Key
ed25753c-488d-4939-93f2-156007783f1c
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 |