Duns Number:345709885
Device Description: The ROG is a chemical based portable oxygen generator which generates 99% oxygen for at le The ROG is a chemical based portable oxygen generator which generates 99% oxygen for at least 15 minutes at a flow rate of at least 6 Lpm. It is a self-contained device with the oxygen delivered via standard oxygen face mask or nasal cannula.
Catalog Number
-
Brand Name
Rugged Oxygen Generator (ROG)
Version/Model Number
EO209P63N29
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K131016,K131016
Product Code
CAW
Product Code Name
Generator, Oxygen, Portable
Public Device Record Key
cf33c996-f360-46f8-a3f6-51b740ea834b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 26, 2016
Package DI Number
05060031380019
Quantity per Package
6
Contains DI Package
05060031380002
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |