Duns Number:834499415
Device Description: Oxygen Concentrator, 1-8 LPM, Dual flow option with standard 1-8 LPM flow meters, Re-manuf Oxygen Concentrator, 1-8 LPM, Dual flow option with standard 1-8 LPM flow meters, Re-manufactured.
Catalog Number
-
Brand Name
NewLife Intensity
Version/Model Number
AS094-1U
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
-
Product Code
CAW
Product Code Name
Generator, Oxygen, Portable
Public Device Record Key
e635de7d-348b-4455-8a9b-65d7ffac721c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 15, 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. | 43 |