Portex

Portex - 100/189/070

A hollow cylinder inserted orally into the trachea to maintain airway patency, typically for patients anticipated to require prolonged mechanical ventilation in critical care, that enables removal of pooled secretion above its distal cuff with suction. It consists of a ventilation lumen, a cuff-inflation lumen, and a suction lumen; a distal inflatable cuff used to form a seal against the tracheal wall; separate connectors that attach to a breathing circuit and suction system; and a pilot balloon for cuff-pressure monitoring. It typically has a radiopaque marker to guide its placement and is available in various diameters/lengths for adult and paediatric patients. This is a single-use device.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: BTR

Device Name: Tube, Tracheal (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: 868.5730

Third Party Flag: N

Medical Specialty: AN

Device Id: 35019315059524

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 15019315059520

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box

Device Id: 15019315059520

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

Device Id: 55019315059528

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 35019315059524

Package Quantity: 12

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case