Duns Number:151860053
Device Description: LIFE®OxygenPac replacement/spare cylinder. Includes cylinder, valve, gauge, and 566 liters LIFE®OxygenPac replacement/spare cylinder. Includes cylinder, valve, gauge, and 566 liters of oxygen. Provides 90 minute supply of oxygen at 6 LPM.
Catalog Number
-
Brand Name
LIFE®Cylinder
Version/Model Number
LIFE-101
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
ECX
Product Code Name
Cylinder, Compressed Gas, And Valve
Public Device Record Key
0f09a12e-0f8f-4b4a-9428-6a99feeb9712
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 |