Duns Number:112942404
Device Description: ISE Sodium Electrode for use with EasyLyte analyzers
Catalog Number
2102
Brand Name
Sodium Electrode
Version/Model Number
2102
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
K864872
Product Code
JGS
Product Code Name
Electrode, Ion Specific, Sodium
Public Device Record Key
427f6959-c9ef-46cc-8eb5-0503c5986dc6
Public Version Date
December 10, 2018
Public Version Number
1
DI Record Publish Date
November 08, 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 |