Duns Number:112569116
Device Description: 1901-76501,PM4150 SERIES,CONCENTRATOR,OXYGEN,PORTABLE, 5 LITER Manufactured by Precision M 1901-76501,PM4150 SERIES,CONCENTRATOR,OXYGEN,PORTABLE, 5 LITER Manufactured by Precision Medical Inc. for Luxfer
Catalog Number
-
Brand Name
Precision Medical Inc. \ Luxfer
Version/Model Number
1901-76501
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 01, 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
K072348
Product Code
CAW
Product Code Name
Generator, Oxygen, Portable
Public Device Record Key
758b0eb2-347a-4e90-bf32-ce46fbfd312d
Public Version Date
April 13, 2021
Public Version Number
5
DI Record Publish Date
May 18, 2016
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 |