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 ID: 08885009190707
• NIH Device Record Key: ef106f31-5a60-4d26-8108-bfcdb11398fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venner™ Tracheal Seal Monitor
• Version Model Number: 903200
• Catalog Number: 903200
• Company DUNS: 659177273
• Company Name: VENNER MEDICAL (SINGAPORE) PTE. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08885009190707 [Primary]
GS1	28885009190701 [Package]; Package: 8 boxes in a carton [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110631

FDA Product Code

• BSK: Cuff, Tracheal Tube, Inflatable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-06
• Device Publish Date: 2016-09-24

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

• 28885009190855 - Venner™ Tracheal Seal Monitor Extension Tube: 2022-07-04 For facilitating the cuff inflation connection between the Venner™ Tracheal Seal Monitor and Venner™ PneuX P.Y.™ Endotrac
• 08885009190707 - Venner™ Tracheal Seal Monitor: 2019-05-06An 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 Monitor: 2019-05-06 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.™ ETT: 2019-05-06 The Venner™ PneuX P.Y.™ Endotracheal tube is designed to be used for patients undergoing Tracheal intubation during extended
• 08885009190738 - Venner™ PneuX P.Y.™ ETT: 2019-05-06 The Venner™ PneuX P.Y.™ Endotracheal tube is designed to be used for patients undergoing Tracheal intubation during extended
• 08885009190745 - Venner™ PneuX P.Y.™ ETT: 2019-05-06 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 MRI: 2019-05-06 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 MRI: 2019-05-06 The Venner™ PneuX P.Y.™ Endotracheal tube is designed to be used for patients undergoing Tracheal intubation during extended