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
MTC6 O2 CGA540 DS _ 9/16 G
Version/Model Number
0721104US
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
d7377ea9-a370-4b5c-9cc3-2a8958d2627c
Public Version Date
February 25, 2021
Public Version Number
1
DI Record Publish Date
February 17, 2021
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 |