Duns Number:045361136
Device Description: To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the IS To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the ISE module of Roche Cobas Chemistry Systems.
Catalog Number
A469-98
Brand Name
Standard 2
Version/Model Number
A469-98
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 31, 2019
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JIX
Product Code Name
Calibrator, Multi-Analyte Mixture
Public Device Record Key
cdebdb1f-3d0a-428d-a6fe-1487edd0cbd7
Public Version Date
December 21, 2020
Public Version Number
5
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 | 69 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |