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 IdentifiersDevice 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