Product Overview

Portex - 450961-NL


Device Description

An assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: CAH

Device Name: Filter, Bacterial, Breathing-Circuit

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HO

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: 868.5260

Third Party Flag: Y

Medical Specialty: AN


Code: BTC

Device Name: Bag, Reservoir

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 868.5320

Third Party Flag: N

Medical Specialty: AN


Code: CAI

Device Name: Circuit, Breathing (W Connector, Adaptor, Y Piece)

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 868.5240

Third Party Flag: N

Medical Specialty: AN


Code: BSJ

Device Name: Mask, Gas, Anesthetic

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 868.5550

Third Party Flag: N

Medical Specialty: AN


Device Identifiers

Device Id: 35019315075913

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 15019315075919

Package Quantity: 20

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CARTON


Device Id: 15019315075919

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


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