Duns Number:785952607
Device Description: OXYGEN TUBE, 2.1M
Catalog Number
-
Brand Name
OXYGEN TUBE, 2.1M
Version/Model Number
1174003
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
d684cac1-06d0-4f94-81a1-e0f1ee38d0d0
Public Version Date
August 05, 2022
Public Version Number
3
DI Record Publish Date
October 11, 2021
Package DI Number
05030267019052
Quantity per Package
100
Contains DI Package
05030267051564
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 222 |
2 | A medical device with a moderate to high risk that requires special controls. | 101 |