Portex

Portex - 100/199/100

A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and 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: JOH

Device Name: Tube Tracheostomy And Tube Cuff

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: 55019315022386

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 35019315022382

Package Quantity: 6

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 35019315022382

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 15019315022388

Package Quantity: 20

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box

Device Id: 15019315022388

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