Duns Number:016523183
Device Description: The ResMed MOBI is used on a prescriptive basis by adult patients who are diagnosed as r The ResMed MOBI is used on a prescriptive basis by adult patients who are diagnosed as requiring supplemental oxygen. The oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life-supporting nor life-sustaining. It may be used continuously in a home, institutional or travel environment. The MOBI is also portable.
Catalog Number
35001
Brand Name
MOBI AMER1
Version/Model Number
35001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 15, 2018
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
-
Product Code
CAW
Product Code Name
Generator, Oxygen, Portable
Public Device Record Key
838fe8af-b511-4b0d-adb2-873d2ce30aa6
Public Version Date
October 13, 2020
Public Version Number
3
DI Record Publish Date
April 26, 2018
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. | 10 |