Duns Number:112569116
Device Description: LX1900 Series Oxygen Conserving Regulator, Easy Pulse, Luxfer
Catalog Number
-
Brand Name
Precision Medical Inc.
Version/Model Number
LX1900 Series
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 30, 2017
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
NFB
Product Code Name
Conserver, Oxygen
Public Device Record Key
532f17b2-90ba-410a-a06e-b37e07bf12a8
Public Version Date
October 11, 2021
Public Version Number
5
DI Record Publish Date
August 29, 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 |