Duns Number:039981550
Device Description: Carbon Dioxide (CO2) TabletEach tablet is individually sealed in a ten-pack foil pouch. Su Carbon Dioxide (CO2) TabletEach tablet is individually sealed in a ten-pack foil pouch. Supplied with ten zip lock bags.
Catalog Number
CO2BAG
Brand Name
N/A
Version/Model Number
CO2BAG
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
-
Product Code
JSK
Product Code Name
Supplement, Culture Media
Public Device Record Key
db7f21d8-e066-452f-b443-a3945fb76325
Public Version Date
August 20, 2020
Public Version Number
1
DI Record Publish Date
August 12, 2020
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 | 630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |