Duns Number:080216804
Device Description: O2-Life Oxygen Tubing 21' (6.4m) Crush Resistant Standard Connector
Catalog Number
RTG-06004
Brand Name
O2-Life™
Version/Model Number
RTG-06004
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
Yes
For Single-Use
Yes
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
GAZ
Product Code Name
Tubing, Noninvasive
Public Device Record Key
64333e97-273e-4646-a2b9-0da7dbaf2f50
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
10850108006728
Quantity per Package
25
Contains DI Package
00850108006721
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 54 |