Duns Number:023904428
Device Description: Oxygen Regulator STANDARD CGA870 CONNECTION BARB OUTLET T-HANDLE GREEN 0-15 LP Oxygen Regulator STANDARD CGA870 CONNECTION BARB OUTLET T-HANDLE GREEN 0-15 LPM (20/cs)
Catalog Number
-
Brand Name
McKesson
Version/Model Number
146-18302GN
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"
Yes
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
7d1471ff-6431-4f84-9c2c-2b6501721fb8
Public Version Date
January 27, 2022
Public Version Number
1
DI Record Publish Date
January 19, 2022
Package DI Number
00612479262034
Quantity per Package
20
Contains DI Package
00612479262027
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |