Duns Number:045623154
Device Description: ISE Standard - Low For the standardization of Sodium, Potassium and Chloride on Ion Select ISE Standard - Low For the standardization of Sodium, Potassium and Chloride on Ion Selective Electrodes.packaged at 10 x 2ml
Catalog Number
HI790-STL
Brand Name
Pointe Scientific
Version/Model Number
HI790-STL
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
K051646
Product Code
JGS
Product Code Name
Electrode, Ion Specific, Sodium
Public Device Record Key
1f7a88b9-5c55-4206-af97-466a0d2e599a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |