Duns Number:151860053
Device Description: LIFE®SoftPac Emergency Oxygen Unit is lightweight (6 lbs) for easy portability and frequen LIFE®SoftPac Emergency Oxygen Unit is lightweight (6 lbs) for easy portability and frequent carrying. A 6&12 LPM (NORM & HIGH), variable-flow regulator provides a 40 minute supply of oxygen at 6LPM.
Catalog Number
-
Brand Name
LIFE®SoftPac
Version/Model Number
LIFE-2-612
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
Yes
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
d08aaf1f-fcf6-4d8f-b94a-665ba7bba20b
Public Version Date
March 10, 2021
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 |