Portex

Portex - 27-7001

A hand-held, non-powered device designed to remove excessive mucus or sputum (phlegm) from the lungs and upper airways using positive pressure airway (PEP) to treat patients affected by acute or chronic lung disease. PEP is created when a patient exhales into the device which creates vibrations in the chest by various means (e.g., an oscillating ball or creating bubbles in a solution within the device) loosening the mucus for expectoration and assisting in lung expansion. Also known as an oscillating positive expiratory pressure (OPEP) device, it is a single-patient device designed for use both in a healthcare facility and in the home. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: BWF

Device Name: Spirometer, Therapeutic (Incentive)

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: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 868.5690

Third Party Flag: Y

Medical Specialty: AN

Device Id: 50788942270013

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10788942270015

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 10788942270015

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