Duns Number:659177273
Device Description: The Venner™ PneuX P.Y.™ Tracheostomy tube is designed to be used for patients undergoing T
Catalog Number
902170
Brand Name
Venner™ PneuX P.Y.™ TT MRI
Version/Model Number
902170
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
60d850a4-d4ee-4a82-82c4-c985cb2b3add
Public Version Date
June 05, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
28885009190824
Quantity per Package
10
Contains DI Package
18885009190827
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 |