Duns Number:151860053
Device Description: Oxygen regulator providing variable 6 & 12 LPM flow-rates. For use with LIFE® Emergency Ox Oxygen regulator providing variable 6 & 12 LPM flow-rates. For use with LIFE® Emergency Oxygen Units.
Catalog Number
-
Brand Name
LIFE®Regulator
Version/Model Number
LIFE-612 Regulator
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAN
Product Code Name
Regulator, Pressure, Gas Cylinder
Public Device Record Key
a521a5a6-2ab0-4ff5-9d9e-2e8366a3af3e
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
June 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 | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |