Duns Number:112942404
Device Description: ISE Lithium Electrode for use with EasyLyte analyzers
Catalog Number
2106
Brand Name
Lithium Electrode
Version/Model Number
2106
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
K914810
Product Code
JIH
Product Code Name
Flame Photometry, Lithium
Public Device Record Key
ef9e4355-29b3-47af-9356-d0bdca6b3a68
Public Version Date
March 19, 2021
Public Version Number
2
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 |