Medical device licence · 115248 · Class 2
BREATHING CIRCUIT KIT
Yes: licensed in Canada
Licence status Issued (active); first licensed April 21, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 115248
- Licence holder
- Fisher And Paykel Healthcare Ltd.Auckland, New Zealand
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- April 21, 2026
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADULT BREATHING CIRCUIT INSPIRATORY HEATED WITH MR290 AUTOFEED CHAMBER
- ADULT CPAP LINE HEATED WITH MR290 AUTOFEED CHAMBER
- ADULT OXYGEN THERAPY CIRCUIT HEATED, WITH MR290, RT008 AND RT022
- ADULT OXYGEN THERAPY LINE HEATED WITH MR290 AUTOFEED CHAMBER
- ADULT OXYGEN THERAPY LINE HEATED WITH MR290 CHAMBER AND AIR ENTRAINER
- ADULT VENTILATOR CIRCUIT DUAL HEATED WITH MR290 AUTOFEED CHAMBER
- ADULT VENTILATOR CIRCUIT DUAL HEATED WITH PRESSURE LINE WITH MR290 AUTOFEED CHAMBER
- ADULT VENTILATOR CIRCUIT SINGLE HEATED WITH MR290 AUTO FEED CHAMBER
- BI-LEVEL/CPAP CIRCUIT KIT WITH HEATED LIMB, EXTENSION, MR290 CHAMBER AND RESPIRONICS FILTER-COMPATIBLE EXHALATION PORT (FEP)
- F&P 850 AIRSPIRAL ADULT NIV AND NHF CIRCUIT KIT
- F&P 950 OPTIFLOW JUNIOR HEATED CIRCUIT KIT
- INFANT CONTINUOUS FLOW CIRCUIT (0.3 TO 10 L/MIN) SINGLEHEATED WITH MR290 AUTOFEED CHAMBER AND PRESSURE RELIEF VALVE
- INFANT CONTINUOUS FLOW CIRCUIT (>4 L/MIN) SINGLE HEATED WITH MR290 AUTOFEED CHAMBER
- INFANT VENTILATOR CIRCUIT (0.3 TO 4L/MIN) SINGLE HEATED WITH MR290 AUTOFEED CHAMBER
- INFANT VENTILATOR CIRCUIT (> 4L/MIN) SINGLE HEATED WITH MR290 AUTOFEED CHAMBER
- OPTIFLOW TUBING KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.