- Physicians Office Resource

Tracheal catheter (1)
AVEA - 79018

Device Description

A sterile device intended to be used for monitoring the endotracheal pressure of a mechanically ventilated patient. It consists of a Y-piece component that connects an endotracheal tube to a breathing circuit, with a port for an included sensing catheter to be inserted and advanced through the endotracheal tube into the trachea. It is proximally connected to a parent device (e.g., ventilator), which will measure and display the detected endotracheal pressure. It is typically made of plastic material [e.g., polyvinyl chloride (PVC)]. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: CBK

Device Name: Ventilator, Continuous, Facility Use

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: AN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 868.5895

Third Party Flag: N

Medical Specialty: AN

Device Identifiers

Device Id: 10846446019605

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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