PED/Adult Airway Flow Sensor
Newport - SEN3420A
Device Description
A non-electrical device intended to be used with a mainstream carbon dioxide (CO2) sensor for the determination of CO2 concentration in gases expired from a patient. It is designed as a small, plastic, open-ended vessel with a clear optic window (cuvette) for the acceptance of an infrared sensor [not included] that is slotted over the outside of the window section; some types may additionally feature an adaptor for the acceptance of a gas flow sensor. It typically has connector ports that enable it to be connected into a breathing system (e.g., an anaesthesia or critical care ventilation system). 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: CBK
Device Name: Ventilator, Continuous, Facility Use
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: 868.5895
Third Party Flag: N
Medical Specialty: AN
Device Identifiers
Device Id: 10884521774049
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
