Duns Number:003152968
Device Description: The CO2 Regulator System is intended to supply low pressure CO2, where small volumes of CO The CO2 Regulator System is intended to supply low pressure CO2, where small volumes of CO2 are needed, during medical procedures. The device is not intended to be marketed for any specific treatment or medical purpose.The CO2 Cartridge is a component of the Avinger CO2 Regulator System which also includes a CO2 regulator (regulator), male luer lock connector and a female-female luer lock connector (removable). The Avinger CO2 Regulator System allows for the CO2 cartridge to be replaced once the gas from the engaged CO2 cartridge has been spent. Replacement CO2 Cartridges are shipped in packs of five (5).
Catalog Number
C100
Brand Name
CO2
Version/Model Number
C100
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAN
Product Code Name
Regulator, Pressure, Gas Cylinder
Public Device Record Key
93d82dea-d1de-472d-8b07-88ca2940a1d2
Public Version Date
March 29, 2019
Public Version Number
1
DI Record Publish Date
March 21, 2019
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |