Portex

Portex - 101/858/060

A hollow, cylindrical, curved device designed as an internal, independent component of a metal tracheostomy tube. It is made of metal [e.g., high-grade stainless steel and/or silver (Ag) or silver plated brass] or plastic and has precise dimensions allowing it to fit exactly into the outer tube and function as the inner cannula for tracheostomy tubes that have this kind of function. It is removed once or more times daily to facilitate the removal of phlegm, slime, and contamination build-up, thereby preventing blockage and infection of the stoma and eliminates the traumatic removal of the tracheostomy tube. This is a reusable device.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: BTO

Device Name: Tube, Tracheostomy (W/Wo Connector)

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: 868.5800

Third Party Flag: Y

Medical Specialty: AN

Device Id: 55019517077832

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 35019517077838

Package Quantity: 150

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Carton

Device Id: 35019517077838

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 15019517077834

Package Quantity: 50

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box

Device Id: 15019517077834

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