Duns Number:606814960
Device Description: ISE Standard High for Roche / Hitachi Chemistry Systems
Catalog Number
16-206
Brand Name
Phoenix Diagnostics
Version/Model Number
16-206
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K013451,K013451
Product Code
CGZ
Product Code Name
Electrode, Ion-Specific, Chloride
Public Device Record Key
bed64238-0687-47b1-9385-4517a4e9038d
Public Version Date
March 30, 2020
Public Version Number
4
DI Record Publish Date
April 25, 2017
Package DI Number
10853366007223
Quantity per Package
10
Contains DI Package
00853366007226
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 |