Duns Number:008124539
Device Description: CGA870 Oxygen Regulator, Brass Core w/ Aluminum Sleeve, 0-4 LPM, Barb Outlet
Catalog Number
-
Brand Name
Oxygen Regulator
Version/Model Number
5210
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
dbdeaccf-373d-4109-954a-b7af4673c85a
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
February 04, 2020
Package DI Number
00616784521039
Quantity per Package
5
Contains DI Package
00616784521015
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 |