Duns Number:659177273
Device Description: For facilitating the cuff inflation connection between the Venner PneuX TSM™ and an Venner For facilitating the cuff inflation connection between the Venner PneuX TSM™ and an Venner PneuX™ Endotracheal or Tracheostomy breathing tube.
Catalog Number
903010
Brand Name
Venner PneuX TSM™ Extension Tube(non-sterile)
Version/Model Number
903010
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
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
30820246-8a29-4228-ab0e-66e5c50823da
Public Version Date
August 30, 2019
Public Version Number
1
DI Record Publish Date
August 22, 2019
Package DI Number
18885009190902
Quantity per Package
10
Contains DI Package
08885009190905
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |