Duns Number:606814960
Device Description: Slope Solution 238 for Bayer / Ciba-Corning Blood Gas Systems
Catalog Number
3-211
Brand Name
Phoenix Diagnostics
Version/Model Number
3-211
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
K902267,K902267
Product Code
JIX
Product Code Name
Calibrator, Multi-Analyte Mixture
Public Device Record Key
c89a69d3-1812-4070-bd5f-36eb7fd8ba3d
Public Version Date
March 30, 2020
Public Version Number
4
DI Record Publish Date
August 12, 2017
Package DI Number
10852676007022
Quantity per Package
50
Contains DI Package
00852676007025
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| 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 |