Venner™ Tracheal Seal Monitor 903200

GUDID 08885009190707

An electro-mechanical system for the control of air pressure within the inflation cuff of an Venner™ PneuX P.Y.™ Endotracheal or Tracheostomy tube.

VENNER MEDICAL (SINGAPORE) PTE. LTD.

Endotracheal tube cuff inflator
Primary Device ID08885009190707
NIH Device Record Keyef106f31-5a60-4d26-8108-bfcdb11398fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameVenner™ Tracheal Seal Monitor
Version Model Number903200
Catalog Number903200
Company DUNS659177273
Company NameVENNER MEDICAL (SINGAPORE) PTE. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108885009190707 [Primary]
GS128885009190701 [Package]
Package: 8 boxes in a carton [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BSKCuff, Tracheal Tube, Inflatable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-06
Device Publish Date2016-09-24

Devices Manufactured by VENNER MEDICAL (SINGAPORE) PTE. LTD.

28885009190855 - Venner™ Tracheal Seal Monitor Extension Tube2022-07-04 For facilitating the cuff inflation connection between the Venner™ Tracheal Seal Monitor and Venner™ PneuX P.Y.™ Endotrac
08885009190707 - Venner™ Tracheal Seal Monitor2019-05-06An electro-mechanical system for the control of air pressure within the inflation cuff of an Venner™ PneuX P.Y.™ Endotracheal or Tracheostomy tube.
08885009190707 - Venner™ Tracheal Seal Monitor2019-05-06 An electro-mechanical system for the control of air pressure within the inflation cuff of an Venner™ PneuX P.Y.™ Endotrachea
08885009190714 - Venner™ PneuX P.Y.™ ETT 2019-05-06 The Venner™ PneuX P.Y.™ Endotracheal tube is designed to be used for patients undergoing Tracheal intubation during extended
08885009190721 - Venner™ PneuX P.Y.™ ETT2019-05-06 The Venner™ PneuX P.Y.™ Endotracheal tube is designed to be used for patients undergoing Tracheal intubation during extended
08885009190738 - Venner™ PneuX P.Y.™ ETT2019-05-06 The Venner™ PneuX P.Y.™ Endotracheal tube is designed to be used for patients undergoing Tracheal intubation during extended
08885009190745 - Venner™ PneuX P.Y.™ ETT2019-05-06 The Venner™ PneuX P.Y.™ Endotracheal tube is designed to be used for patients undergoing Tracheal intubation during extended
28885009190756 - Venner™ PneuX P.Y.™ ETT MRI2019-05-06 The Venner™ PneuX P.Y.™ Endotracheal tube is designed to be used for patients undergoing Tracheal intubation during extended
28885009190763 - Venner™ PneuX P.Y.™ ETT MRI2019-05-06 The Venner™ PneuX P.Y.™ Endotracheal tube is designed to be used for patients undergoing Tracheal intubation during extended

Trademark Results [Venner]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VENNER
VENNER
77621249 4305467 Live/Registered
INDIAN OCEAN MEDICAL INC.
2008-11-25
VENNER
VENNER
77621241 not registered Dead/Abandoned
Venner Capital S.A.
2008-11-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.