Duns Number:606814960
Device Description: ISE High Serum Standard for Olympus AU Series Chemistry Systems
Catalog Number
21-105
Brand Name
Phoenix Diagnostics
Version/Model Number
21-105
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K020148,K020148
Product Code
CEM
Product Code Name
Electrode, Ion Specific, Potassium
Public Device Record Key
0d0e1d04-6e80-4f34-81dc-1e5b44ad73b4
Public Version Date
March 30, 2020
Public Version Number
4
DI Record Publish Date
April 25, 2017
Package DI Number
10853366007056
Quantity per Package
4
Contains DI Package
00853366007059
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 37 |