Duns Number:807537683
Device Description: Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English, Single Battery
Catalog Number
-
Brand Name
Arya
Version/Model Number
AS200-6
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K020324
Product Code
CAW
Product Code Name
Generator, Oxygen, Portable
Public Device Record Key
b9acb059-9566-4b6c-aeb3-1a1c2f7337a7
Public Version Date
November 16, 2021
Public Version Number
1
DI Record Publish Date
November 08, 2021
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 252 |