Duns Number:659177273
Device Description: For facilitating the cuff inflation connection between the Venner™ Tracheal Seal Monitor a For facilitating the cuff inflation connection between the Venner™ Tracheal Seal Monitor and Venner™ PneuX P.Y.™ Endotracheal or Tracheostomy breathing tube.
Catalog Number
903001
Brand Name
Venner™ Tracheal Seal Monitor Extension Tube
Version/Model Number
903001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 25, 2019
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"
-
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
0e8a0b9f-de54-454d-b951-e8291d48bfcd
Public Version Date
July 04, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
28885009190855
Quantity per Package
10
Contains DI Package
18885009190858
Package Discontinue Date
February 25, 2019
Package Status
Not in Commercial Distribution
Package Type
10 boxes in a carton
| 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 |