Portex

Portex - 100/905/301

An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: BYE

Device Name: Attachment, Breathing, Positive End Expiratory Pressure

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: 868.5965

Third Party Flag: N

Medical Specialty: AN

Code: BTL

Device Name: Ventilator, Emergency, Powered (Resuscitator)

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: 868.5925

Third Party Flag: N

Medical Specialty: AN

Device Id: 35019315061077

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 15019315061073

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 15019315061073

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