Duns Number:034756852
Device Description: The O2 Concepts Oxlife Freedom is indicated on a prescription basis for the administration The O2 Concepts Oxlife Freedom is indicated on a prescription basis for the administration of supplemental oxygen. It is not intended for life support, nor does it provide any patient monitoring capabilities.
Catalog Number
-
Brand Name
Oxlife Freedom POC
Version/Model Number
301-0003V
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
K182454
Product Code
CAW
Product Code Name
Generator, Oxygen, Portable
Public Device Record Key
a9ea79ac-7783-4a6f-9e42-35c2ee5b8a8e
Public Version Date
April 20, 2020
Public Version Number
2
DI Record Publish Date
April 15, 2019
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. | 3 |