Esophageal Tracheal Airway Double Lumen

Esophageal Tracheal Airway Double Lumen
Mallinckrodt - 5-18241

A two-lumen, semiflexible, single-use tube inserted blindly through the mouth into the oesophagus or trachea to maintain airway patency while obturating the oesophagus, typically during emergencies to facilitate breathing/resuscitation. The oesophageal-obturating lumen has a blocked distal end and perforations at the pharyngeal level. A large oropharyngeal balloon seals mouth and nose; a distal cuff seals either the oesophagus or the trachea. Ventilation starts via the oesophageal tube, if the tube is in the oesophagus air enters the pharynx via the perforations; when the tube is in the trachea the ventilation is performed directly through the tracheal tube. This is a single-use device.

• Catheter Gauge: 41 French

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: CAO

Device Name: Airway, Esophageal (Obturator)

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: 868.5650

Third Party Flag: N

Medical Specialty: AN

Device Id: 10884521105539

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20884521105536

Package Quantity: 4

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 20884521105536

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