ApprovalTrail

Medical device licence · 93030 · Class 3

EVITA V300

Yes: licensed in Canada

Licence status Issued (active); first licensed March 24, 2014. It is in Health Canada’s list of active licences.
Licence number
93030
Licence holder
Draegerwerk Ag & Co. KgaaLubeck, Germany
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
March 24, 2014
Devices covered
41

Devices on this licence

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

  • AIR SUPPLY UNIT GS500
  • AIRWAY PRESSURE RELEASE VENTILATION PC-APRV
  • AUTOFLOW/VOLUME GUARANTEE
  • AUTOMATIC TUBE COMPENSATION
  • BATTERYSET PS500(SERVICE)15AH
  • CABLE
  • CENTRAL SUPPLY CONNECTING HOSE
  • CO2 CUVETTE
  • CO2 MONITORING
  • CONVERSION KIT PB->LIFEPO4
  • DEMO LUNG NEONATAL
  • EVITA V300
  • INFINITY C300
  • INFINITY ID EXPIRATORY FILTER
  • INFINITY ID EXPIRATORY VALVE
  • INFINITY ID FLOW SENSOR
  • INFINITY ID INSPIRATORY VALVE
  • MANDORY MINUTE VENTILATION
  • MCABLE
  • MEMBRANE, COMPLETE
  • MONITORING PLUS
  • NEBULIZER PORT
  • NEONATAL FLOW SENSOR INSERT
  • NEONATAL FLOW SENSOR ISO 15
  • NEONATAL FLOW SENSOR Y-PIECE
  • NEONATAL VENTILATION
  • NON-INVASIVE VENTILATION
  • NURSE CALL
  • O2 CONNECTION HOSE
  • O2 THERAPY INHALATION UNIT
  • POWER SUPPLY UNIT PS500
  • PRESSURE SUPPORT VENTILATION
  • PROPORTIONAL PRESSURE SUPPORT
  • PS500 LIFEPO4
  • SMART PULMONARY VIEW
  • SMARTCARE/PS
  • SOFTWARE PROTOCOL
  • STANDBY HOLDER FOR CO2 SENSOR WITHOUT CALIBRATION
  • T-ADAPTER
  • TEST LUNG, COMPLETE, PEDIATRIC PATIENTS
  • TRANSPORT SUPPLY UNIT

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