ApprovalTrail

Medical device licence · 94534 · Class 2

BREATHING SYSTEMS

Yes: licensed in Canada

Licence status Issued (active); first licensed January 15, 2015. It is in Health Canada’s list of active licences.
Licence number
94534
Licence holder
Intersurgical Ltd.East Syracuse, NY, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Group Family
First licensed
January 15, 2015
Devices covered
91

Devices on this licence

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

  • 15MM FLEXTUBE BREATHING SYSTEM WITH LUER ELBOW AND SINGLE WATER TRAP
  • 22MM DRI-THERM DUAL HEATED WIRE BREATHING SYSTEM WITH AUTO-FILL CHAMBER AND EXTRA LIMB
  • 22MM DUOFLOW BI LUMEN BREATHING SYSTEM WITH 2L BAG, ELBOW, INTEGRAL MONITORING LINE AND LIMB
  • 22MM DUOFLOW BI LUMEN BREATHING SYSTEM WITH 2L BAG, LUER ELBOW AND LIMB
  • 22MM DUOFLOW BI LUMEN BREATHING SYSTEM WITH ELBOW AND INTEGRAL MONITORING LINE
  • 22MM DUOFLOW BI LUMEN BREATHING SYSTEM WITH LUER ELBOW
  • 22MM FLEXTUBE BREATHING SYSTEM WITH 21 BAG, INTEGRAL MONITORING LINE, LIMB
  • 22MM FLEXTUBE TRANSPORT BREATHING SYSTEM FOR THE OXYLOG
  • 22MM SMOOTHBORE ADULT, COUGH ASSIST BREATHING SYSTEM WITH MASK AND FLO-GUARD FILTER
  • ABS PAEDIATRIC BREATHING SYSTEMS
  • ADULT BREATHING SYSTEMS WITH HEATED WIRE
  • ADULT FLEX TUBE BREATHING SYSTEMS WITH HEATED WIRE
  • ADULT FLEXTUBE BREATHING SYSTEMS
  • ADULT SMOOTHBORE BREATHING SYSTEMS
  • ADULT SMOOTHBORE BREATHING SYSTEMS WITH HEATED WIRE
  • ADULT TRANSPORT BREATHING SYSTEMS
  • ANAESTHETIC BREATHING SYSTEM
  • ANAESTHETIC BREATHING SYSTEM, MAPLESON F INFANT T-PIECE
  • ANESTHETIC BREATHING SYSTEMS
  • ANTI-MICROBIAL BREATHING SYSTEM
  • ANTIMICROBIAL BREATHING SYSTEMS FOR AISYS & AESPIRE MACHINES
  • BASIC UNIFLOW SYSTEM
  • BILEVEL BREATHING SYSTEMS
  • BONDED SMOOTHBORE
  • BREATHING SYSTEM FOR DRAEGER AQUAPORE
  • BREATHING SYSTEM PAEDIATRIC
  • BREATHING SYSTEM WATER TRAPS
  • BREATHING SYSTEM WITH LUER ELBOW
  • BREATHING SYSTEM, ENTONOX, WITH MASK
  • BREATHING SYSTEM, ENTONOX, WITH MOUTHPIECE
  • BREATHING SYSTEM, SILICONE
  • BREATHING SYSTEMS FOR MR730/850 BREATHING CIRCUIT
  • BREATHING SYSTEMS WITH EXHALATION VALVE
  • CLEAR HYTREL BREATHING SYSTEM
  • CLEAR-FLO ANAESTHETIC BREATHING SYSTEM
  • COMPACT BAGGING LIMB
  • COMPACT BREATHING SYSTEMS
  • COMPACT II SYSTEM, LIMB, RES BAG + FILTER
  • COMPACT O2/N2O BREATHING SYSTEM WITH ONE WAY VALVES
  • COMPACT, B/S WITH BAG AND LIMB
  • COMPACT, EXTENDABLE BREATHING SYSTEM WITH TWO RESEALABLE WATER TRAPS AND LIMB
  • CPAP BREATHING SYSTEM
  • CUSTOM ANAESTHETIC SYSTEMS
  • DUAL HEATED WIRE SYSTEM
  • F/TUBE DUAL H/WIRE B/SYS
  • FLEXTUBE
  • FLEXTUBE B/S
  • FLEXTUBE BREATHING SYSTEM WITH 2L BAG, INTEGRAL MONITORING LINE AND LIMB
  • FLEXTUBE BREATHING SYSTEM WITH FLOW SENSOR
  • FLEXTUBE BREATHING SYSTEM WITH INTEGRAL MONITORING LINE
  • FLEXTUBE COAXIAL BREATHING SYSTEM WITH FLOW SENSOR
  • FLEXTUBE SILVER KNIGHT ANTI-MICROBIAL BREATHING SYSTEM WITH BAG, AND INTEGRAL MONITORING LINE
  • FLEXTUBE SILVER KNIGHT ANTI-MICROBIAL BREATHING SYSTEM WITH INTEGRAL MONITORING LINE
  • FLEXTUBE SILVER KNIGHT ANTI-MICROBIAL LIMB
  • FLEXTUBE SINGLE HEATED WIRE BREATHING SYSTEM
  • FLEXTUBE TINTED BLUE CUFFED
  • FLEXTUBE, CUFFED
  • HEATED WIRE BREATHING SYSTEMS
  • INDIVIDUAL TUBES
  • IPPB BREATHING SYSTEMS
  • LOW FLOW DUAL H/WIRE SYSTEM
  • LOW FLOWS SINGLE H/WIRE SYSTEM
  • MANUAL RESUSCITATION BREATHING SYSTEMS
  • MANUAL RESUSCITATION SYSTEM INFANT
  • MANUAL RESUSCITATION SYSTEM SMALL ADULT
  • MAPLESON BREATHING SYSTEM
  • MAPLESON COAXIAL BREATHING SYSTEMS
  • NEONATAL RESUSCITATION BREATHING SYSTEMS
  • NEONATAL RESUSCITATION SYSTEM
  • SILICONE MONOBLOC BREATHING HOSE
  • SILVER KNIGHT ANTI-MICROBIAL BREATHING SYSTEMS
  • SILVER KNIGHT BREATHING SYSTEMS
  • SILVER KNIGHT DUAL HEATED WIRE SYSTEM
  • SILVER KNIGHT STANDARD UNIFLOW CO-AXIAL SYSTEM
  • SILVER KNIGHT UNIFLOW COAXIAL BREATHING SYSTEM WITH INTEGRAL MONITORING LINE AND LIMB
  • SMOOTHBORE BREATHING NEONATAL SYSTEM
  • SMOOTHBORE BREATHING SYSTEM PAEDIATRIC
  • SMOOTHBORE BREATHING SYSTEMS
  • SMOOTHBORE DUAL HEATED BREATHING SYSTEM
  • SMOOTHBORE SINGLE H/WIRE SYSTEM
  • SMOOTHBORE SINGLE HEATED B/S
  • SPECIAL ADULT BREATHING SYSTEMS
  • SPECIAL ADULT FLEXTUBE BREATHING SYSTEMS
  • STANDARD UNIFLOW SYSTEM
  • TUBING
  • UNIFLOW COAXIAL BREATHING SYSTEM
  • UNIFLOW SILVER KNIGHT ANTI-MICROBIAL COAXIAL BREATHING SYSTEM WITH BAG, AND INTEGRAL MONITORING LINE
  • UNIFLOW SILVER KNIGHT ANTI-MICROBIAL COAXIAL BREATHING SYSTEM WITH LUER ELBOW
  • UNIFLOW SILVER KNIGHT COAXIAL BREATHING SYSTEM WITH LUER ELBOW
  • UNIVERSAL NEONATAL RESUSCITATION SYSTEM VARIABLE PEEP
  • UNIVERSAL SINGLE HEATED WIRE SYSTEM

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