Medical device licence · 67264 · Class 2
BREATHING TUBES
Yes: licensed in Canada
Licence status Issued (active); first licensed February 1, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 67264
- 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
- February 1, 2005
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADULT ANAESTHESIA CIRCUIT
- ADULT NON HEATED DUAL WATERTRAP CIRCUIT
- ADULT OXYGEN THERAPY LINE HEATED
- ADULT RESPIRATORY CIRCUIT DUAL HEATED
- ADULT VENTILATOR CIRCUIT SINGLE HEATED
- ADULT VENTILATOR CIRCUIT SINGLE HEATED WITH PRESSURE LINE
- BI-LEVEL CPAP CIRCUIT
- BI-LEVEL/CPAP CIRCUIT
- BI-LEVEL/CPAP LIMB HEATED WITH EXTENSION AND RESPIRONICS EXHALATION PORT
- BREATHING TUBE SU CATHETER MOUNT
- IN LINE INFANT NEBULIZER KIT
- INFANT CONTINUOUS FLOW CIRCUIT (>4 L/MIN) SINGLE HEATED
- INFANT VENTILATOR CIRCUIT (0.3 TO 4L/MIN) SINGLE HEATED
- INFANT VENTILATOR CIRCUIT (> 4L/MIN) SINGLE HEATED
- INFANT VENTILATOR CIRCUIT SINGLE HEATED
- INFANT VENTILATOR CIRCUIT SINGLE HEATED FOR SLE2000 & SLE2000 HFO VENTILATORS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.