Duns Number:785952607
Device Description: OXYGEN TUBE, 2.1M, NON PVC
Catalog Number
-
Brand Name
OXYGEN TUBE, 2.1M, NON PVC
Version/Model Number
1174010
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
4497c2ed-04a8-4211-8447-512218535ef8
Public Version Date
August 05, 2022
Public Version Number
3
DI Record Publish Date
October 11, 2021
Package DI Number
05030267103133
Quantity per Package
100
Contains DI Package
05030267102747
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 |