ApprovalTrail

Medical device licence · 9957 · Class 3

840 VENTILATOR SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed August 16, 1999. It is in Health Canada’s list of active licences.
Licence number
9957
Licence holder
Covidien LlcChicopee, MA, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
August 16, 1999
Devices covered
18

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • 840 VENTILATOR SYSTEM - BILEVEL UPGRADE KIT
  • 840 VENTILATOR SYSTEM - CD UPGRADE KIT
  • 840 VENTILATOR SYSTEM - EXPANDED NEO MODE UPGRADE KIT
  • 840 VENTILATOR SYSTEM - EXPANDED NEO-MODE OPTION KIT
  • 840 VENTILATOR SYSTEM - FLEXIBLE ARM
  • 840 VENTILATOR SYSTEM - LEAK COMPENSATION OPTION KIT
  • 840 VENTILATOR SYSTEM - LEAK COMPENSATION UPGRADE KIT
  • 840 VENTILATOR SYSTEM - MAIN UNIT
  • 840 VENTILATOR SYSTEM - NEO-MODE (SW ONLY) UPGRADE KIT
  • 840 VENTILATOR SYSTEM - NEOMODE OPTION UPGRADE KIT AND ACCESSORIES
  • 840 VENTILATOR SYSTEM - PAV UPGRADE KIT
  • 840 VENTILATOR SYSTEM - RESPIRATORY MECHANICS OPTION KIT
  • 840 VENTILATOR SYSTEM - REUSABLE ADULT BREATHING CIRCUIT
  • 840 VENTILATOR SYSTEM - REUSABLE PEDIATRIC BREATHING CIRCUIT
  • 840 VENTILATOR SYSTEM - TEST LUNG
  • 840 VENTILATOR SYSTEM - TUBING
  • 840 VENTILATOR SYSTEM - UPGRADE KIT, VV+
  • 840 VETILATOR SYSTEM - OXYGEN SENSOR

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.