Duns Number:112942404
Device Description: EasyStat Chloride Electrode for use with EasyStat Analyzers
Catalog Number
7208
Brand Name
Chloride Electrode
Version/Model Number
7208
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K063376
Product Code
CGZ
Product Code Name
Electrode, Ion-Specific, Chloride
Public Device Record Key
c1ab4b64-9051-4615-9113-8847419cabb5
Public Version Date
January 07, 2019
Public Version Number
1
DI Record Publish Date
December 05, 2018
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 82 |