ApprovalTrail

Medical device licence · 6989 · Class 3

SIII HEART LUNG MACHINE MODULAR SYSTEM

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed January 21, 2000; ended September 26, 2019. It is in Health Canada’s archive of licences no longer in force.
Licence number
6989
Licence holder
Livanova Deutschland GmbhMunich, Germany
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
January 21, 2000
Ended
September 26, 2019
Devices covered
39

Devices on this licence

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

  • CONTROL AND MONITORING UNIT - CARDIOPLEGIA CONTROL
  • CONTROL AND MONITORING UNIT - CONTROL DESK
  • CONTROL AND MONITORING UNIT - DUAL PRESSURE CONTROL
  • CONTROL AND MONITORING UNIT - LEVEL CONTROL/BUBBLE DETECTOR
  • CONTROL AND MONITORING UNIT - PULSATILE FLOW CONTROL PFC
  • CONTROL AND MONITORING UNIT - TEMPERATURE MONITOR
  • CONTROL AND MONITORING UNIT - TIMER
  • GAS FLOW CONTROL AND MEASURING DEVICES - MECHANICAL GAS FLOW METER
  • S III HEART LUNG MACHINE MODULAR SYSTEM - MAIN UNIT
  • S III HEART LUNG MACHINE MODULAR SYSTEM : AIR/OXYGEN MIXER
  • S III HEART LUNG MACHINE MODULAR SYSTEM : CARDIOPLEDGIA CONTROL
  • S III HEART LUNG MACHINE MODULAR SYSTEM : CONTROL DESK
  • S III HEART LUNG MACHINE MODULAR SYSTEM : DATA MANAGEMENT
  • S III HEART LUNG MACHINE MODULAR SYSTEM : DATA MANAGEMENT SYSTEM
  • S III HEART LUNG MACHINE MODULAR SYSTEM : DOUBLE HEAD PUMP
  • S III HEART LUNG MACHINE MODULAR SYSTEM : DUAL PRESSURE CONTROL
  • S III HEART LUNG MACHINE MODULAR SYSTEM : FIBRILLATOR
  • S III HEART LUNG MACHINE MODULAR SYSTEM : HEATER-COOLER SYSTEM
  • S III HEART LUNG MACHINE MODULAR SYSTEM : LEVEL CONTROL/BUBBLE DETECTOR
  • S III HEART LUNG MACHINE MODULAR SYSTEM : MECHANICAL GAS FLOW METER
  • S III HEART LUNG MACHINE MODULAR SYSTEM : PULSATILE FLOW CONTROL PFC
  • S III HEART LUNG MACHINE MODULAR SYSTEM : ROLLER PUMP
  • S III HEART LUNG MACHINE MODULAR SYSTEM : TEMPERATURE MONITOR
  • S III HEART LUNG MACHINE MODULAR SYSTEM : TIMER
  • S III HEART LUNG MACHINE MODULAR SYSTEM : VENOUS RETURN CONTROL DEVICES
  • S III HEART LUNG MACHINE MODULAR SYSTEM : WATER MIXER
  • SIII HEART LUNG MACHINE MODULAR SYSTEM - AIR PURGE CONTROL (APC)
  • SIII HEART LUNG MACHINE MODULAR SYSTEM - CABLE 24
  • SIII HEART LUNG MACHINE MODULAR SYSTEM - CONNECT MANAGER SOFTWARE
  • SIII HEART LUNG MACHINE MODULAR SYSTEM - CONNECT RECORDER SOFTWARE
  • SIII HEART LUNG MACHINE MODULAR SYSTEM - DATA PAD II
  • SIII HEART LUNG MACHINE MODULAR SYSTEM - INTERFACE MODULE
  • SIII HEART LUNG MACHINE MODULAR SYSTEM - SORIN CONNECT UPGRADE COMPLETE
  • SIII HEART LUNG MACHINE MODULAR SYSTEM - SORIN HEART LINK SET
  • SIII HEART LUNG MACHINE MODULAR SYSTEM- SORIN CONNECT COMPLETE
  • SORIN DATAPAD III
  • TEMPERATURE-REGULATION UNIT - HEATER-COOLER SYSTEM
  • TEMPERATURE-REGULATION UNIT - WATER MIXER
  • VENOUS RETURN CONTROL DEVICES - VENOUS LINE CLAMP (MAST MOUNTED)

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