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 Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator 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