Duns Number:008124539
Device Description: Resp-O2 Mini Oxygen Regulator, CGA 870 Style, Barb Outlet, Brass-Sleeved, Flow Range: 0-25 Resp-O2 Mini Oxygen Regulator, CGA 870 Style, Barb Outlet, Brass-Sleeved, Flow Range: 0-25 LPM
Catalog Number
-
Brand Name
Resp-O2 Mini Oxygen Regulator, CGA 870 Style
Version/Model Number
36357
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
-
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
cdca04e7-13c9-4656-b13e-cd429e3948c1
Public Version Date
May 26, 2022
Public Version Number
1
DI Record Publish Date
May 18, 2022
Package DI Number
00840117310070
Quantity per Package
5
Contains DI Package
00840117310063
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |