Duns Number:659177273
Device Description: The Venner™ PneuX P.Y.™ Tracheostomy tube is designed to be used for patients undergoing T The Venner™ PneuX P.Y.™ Tracheostomy tube is designed to be used for patients undergoing Tracheal intubation during extended periods (not more than 30 days) of intensive or critical care, and for evacuation or drainage of secretion from the subglottic space.
Catalog Number
902090
Brand Name
Venner™ PneuX P.Y.™ TT
Version/Model Number
902090
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)
Yes
FDA Premarket Submission
K100950,K100950,K100950
Product Code
BTO
Product Code Name
Tube, Tracheostomy (W/Wo Connector)
Public Device Record Key
af366679-5efa-45f6-b82e-855f16e9dd00
Public Version Date
June 05, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
18885009190810
Quantity per Package
10
Contains DI Package
08885009190813
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
10 pouches in a 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 |