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. It is also safety in an MRI environment (indicated MRI).
Catalog Number
902190
Brand Name
Venner™ PneuX P.Y.™ TT MRI
Version/Model Number
902190
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
18c4bcd2-8a79-403a-a7f4-2bd21ab35b55
Public Version Date
June 05, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
28885009190848
Quantity per Package
10
Contains DI Package
18885009190841
Package Discontinue Date
-
Package Status
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 |