ApprovalTrail

Medical device licence · 109212 · Class 2

RESUSCITATOR BAGS

Yes: licensed in Canada

Licence status Issued (active); first licensed April 13, 2023. It is in Health Canada’s list of active licences.
Licence number
109212
Licence holder
Flexicare Medical Ltd.Mountain Ash, United Kingdom
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
April 13, 2023
Devices covered
45

Devices on this licence

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

  • ADULT RESUSCITATOR, MASK SIZE 5 W/CORRUGATED TUBING
  • ADULT RESUSCITATOR, PRESSURE RELIEF 40CMH20, MASK SIZE 5 W/CORRUGATED TUBING
  • ADULT RESUSCITATOR, PRESSURE RELIEF 60CMH20, MASK SIZE 5 W/CORRUGATED TUBING
  • ADULT REUSABLE RESUSCITATOR MASK SIZE 5 CASE
  • ADULT REUSABLE RESUSCITATOR WITH PRESSURE RELIEF 60CMH20 + MASK SIZE 5 + MANOMETER
  • ADULT REUSABLE RESUSCITATOR WITH PRESSURE RELIEF 60CMH20 AND MASK SIZE 5
  • ADULT REUSABLE RESUSCITATOR WITHOUT PRESSURE RELIEF + MASK SIZE 5
  • ADULT S/USE RESUSCITATOR BAG NO PRESSURE RELIEF, MASK SIZE 5
  • ADULT S/USE RESUSCITATOR, P/RELIEF 40CMH20, MASK SIZE 5
  • ADULT SINGLE USE RESUSCITATOR & PRESSURE RELIEF 60CMH20 &MASK SIZE 5 &HEPASHIELD BVF WITH LUER PORT
  • ADULT SINGLE USE RESUSCITATOR + PRESSURE RELIEF 40CMH20 + MASK SIZE 5
  • ADULT SINGLE USE RESUSCITATOR + STRAP + PRESSURE RELIEF 40CMH20 + MASK SIZE 5
  • ADULT SINGLE USE RESUSCITATOR + STRAP + PRESSURE RELIEF 60CMH20 + MASK SIZE 5
  • ADULT SINGLE USE RESUSCITATOR + STRAP + PRESSURE RELIEF 60CMH20 + MASK SIZE 5 + M/MS 10FT LINE
  • ADULT SINGLE USE RESUSCITATOR BAG + PEEP VALVE, MASK SIZE 5
  • ADULT SINGLE USE RESUSCITATOR BAG, MASK SIZE 5
  • ADULT SINGLE USE RESUSCITATOR WITH PRESSURE RELIEF 60CMH20 + MASK SIZE 5 + ADJUSTABLE PEEP VALVE
  • ADULT SINGLE USE RESUSCITATOR WITH PRESSURE RELIEF 60CMH20 + MASK SIZE 5 + MANOMETER
  • ADULT SINGLE USE RESUSCITATOR WITH PRESSURE RELIEF 60CMH20 AND MASK SIZE 4 + 3 M STAR LUMEN TUBE
  • ADULT SINGLE USE RESUSCITATOR WITH PRESSURE RELIEF 60CMH20 AND MASK SIZE 5
  • ADULT SINGLE USE RESUSCITATOR WITHOUT PRESSURE RELIEF + MASK SIZE 5
  • ADULT SINGLE USE RESUSCITATOR WITHOUT PRESSURE RELIEF NO STRAP + MASK SIZE 5
  • ADULT, PEDIATRIC & INFANT SINGLE USE RESUSCITATION PACK
  • ADULT- PAEDIATRIC & INFANT SINGLE USE RESUSCITATION PACK
  • INFANT RESUSCITATOR, PRESSURE RELIEF 40CMH20, MASK SIZE 0 AND 1, W/CORRUGATED TUBING
  • INFANT REUSABLE RESUSCITATOR MANOMETER MASKS 1 R + 0 R
  • INFANT REUSABLE RESUSCITATOR MASKS 1 R + 0 R CASE
  • INFANT REUSABLE RESUSCITATOR PEEP VALVE MASKS 1 R + 0 R
  • INFANT REUSABLE RESUSCITATOR WITH PRESSURE RELIEF 40CMH20 AND MASK SIZES 1 + 0 ROUND
  • INFANT S/USE RESUS BAG, MASK SIZE 1, ROUND MASK SIZE 0
  • INFANT S/USE RESUS BAG, PEEP VALVE, MASK SIZE 1,ROUND MASK 0
  • INFANT SINGLE USE RESUSCITATOR + PRESSURE RELIEF 40CMH20 + MASK SIZE 1 + MASK SIZE 0 ROUND
  • INFANT SINGLE USE RESUSCITATOR + PRESSURE RELIEF 40CMH20 +MASK SIZE 1 +MASK SIZE 0 ROUND +PEEP VALVE
  • PAEDIATRIC REUSABLE RESUSCITATOR MANOMETER MASK SIZE 3
  • PAEDIATRIC REUSABLE RESUSCITATOR WITH PRESSURE RELIEF 40CMH20 AND MASK SIZE 3
  • PAEDIATRIC SINGLE USE RESUSCITATOR + PRESSURE RELIEF 40CMH20 MASK SIZE 2 + MASK SIZE 1 ROUND
  • PAEDIATRIC SINGLE USE RESUSCITATOR + PRESSURE RELIEF 40CMH20 MASK SIZE 2+MASK SIZE 1 ROUND MANOMETER
  • PAEDIATRIC SINGLE USE RESUSCITATOR+PRESSURE RELIEF 40CMH20 MASK SIZE 2+MASK SIZE 1 ROUND+PEEP VALVE
  • PEDIATRIC SINGLE USE RESUSCITATOR + PRESSURE RELIEF 40CMH20 + MASK SIZE 3
  • PEDIATRIC SINGLE USE RESUSCITATOR + PRESSURE RELIEF 40CMH20 MASK SIZE 2 + MASK SIZE 1 ROUND
  • REUSABLE MANUAL RESUSCITATOR REPLACEMENT INTAKE END ASSEMBLY
  • REUSABLE MANUAL RESUSCITATOR REPLACEMENT PATIENT END ASSEMBLY WITH PRESSURE RELIEF VALVE 40CMH20
  • REUSABLE MANUAL RESUSCITATOR REPLACEMENT PATIENT END ASSEMBLY WITH PRESSURE RELIEF VALVE 60CMH20
  • REUSABLE MANUAL RESUSCITATOR REPLACEMENT PATIENT END ASSEMBLY WITHOUT PRESSURE RELIEF
  • SINGLE USE MANOMETER FOR USE WITH MANUAL RESUSCITATOR

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