Duns Number:819753190
Device Description: The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the p The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
Catalog Number
-
Brand Name
VM O2 CGA870 _ _ 9/16 S
Version/Model Number
0729108US
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2022
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
-
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
0e9cfebc-f979-4f46-883d-1a90c94dfc0a
Public Version Date
April 08, 2022
Public Version Number
1
DI Record Publish Date
March 31, 2022
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 | 96 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |