Duns Number:112569116
Device Description: PM4155, Active Five, Portable Oxygen Concentrator
Catalog Number
-
Brand Name
Precision Medical Inc.
Version/Model Number
PM4155 Portable Oxygen Concentrator
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K103563
Product Code
CAW
Product Code Name
Generator, Oxygen, Portable
Public Device Record Key
9be4dc31-8cab-4452-b6cc-a48abc339331
Public Version Date
April 20, 2020
Public Version Number
3
DI Record Publish Date
May 23, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 106 |