Duns Number:227530649
Device Description: The device is intended for the quantitative in vitro determination of carbon dioxide in se The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma.
Catalog Number
CD116
Brand Name
CO2
Version/Model Number
CD116
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 16, 2016
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K951221
Product Code
KHS
Product Code Name
Enzymatic, Carbon-Dioxide
Public Device Record Key
ff76ff7d-e865-4bc5-b691-c2b8b8da5a48
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 09, 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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |