Duns Number:659177273
Device Description: An electro-mechanical system for the control of air pressure within the inflation cuff of An electro-mechanical system for the control of air pressure within the inflation cuff of an Venner™ PneuX P.Y.™ Endotracheal or Tracheostomy tube.
Catalog Number
903200
Brand Name
Venner™ Tracheal Seal Monitor
Version/Model Number
903200
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"
-
For Single-Use
-
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
K110631,K110631
Product Code
BSK
Product Code Name
Cuff, Tracheal Tube, Inflatable
Public Device Record Key
ef106f31-5a60-4d26-8108-bfcdb11398fb
Public Version Date
May 06, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
28885009190701
Quantity per Package
8
Contains DI Package
08885009190707
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
8 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 |