Duns Number:227530649
Device Description: Intended for use with the Ion Selective Electrode unit for measuring concentration of elec Intended for use with the Ion Selective Electrode unit for measuring concentration of electrolytes in the blood serum, plasma or urine.
Catalog Number
D200-0015
Brand Name
I.S.E. K
Version/Model Number
D200-0015
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K024014
Product Code
CEM
Product Code Name
Electrode, Ion Specific, Potassium
Public Device Record Key
0b988a9c-5bb7-4503-9ef8-c13653971ea4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |