Duns Number:006320915
Device Description: The Oxygen Generator and Liquefier (OGL) is a portable oxygen generating and liquefaction The Oxygen Generator and Liquefier (OGL) is a portable oxygen generating and liquefaction system, capable of producing up to 15 liters per minute of gaseous 93% USP oxygen for medical use or 1 liter of LOX per hour. Up to 40 liters of LOX can be stored in the internal tank until needed. The system features a user-friendly control panel and an insulated transfer hose which will work with any portable LOX device having a standard CRU-50 fill connection.
Catalog Number
50C-0103-5
Brand Name
Oxygen Generator and Liquifier
Version/Model Number
50C-0103-5
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K131990
Product Code
CAW
Product Code Name
Generator, Oxygen, Portable
Public Device Record Key
6cf49406-1c47-4bba-8db1-c5e6619a7475
Public Version Date
April 20, 2020
Public Version Number
4
DI Record Publish Date
December 14, 2015
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |