Duns Number:015954530
Device Description: CGA-870 WITH M9 OXYGEN CYLINDER
Catalog Number
-
Brand Name
CGA-870 WITH OXYGEN CYLINDER
Version/Model Number
CYLM9TFV
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 15, 2021
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
-
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
dc969d78-8b6c-4c67-8bc2-029b03da4fea
Public Version Date
October 18, 2021
Public Version Number
3
DI Record Publish Date
May 11, 2018
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 | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 29 |