Medical device licence · 71499 · Class 2
SINGLE USE FACE MASK
Yes: licensed in Canada
Licence status Issued (active); first licensed June 1, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 71499
- Licence holder
- Fisher And Paykel Healthcare Ltd.Auckland, New Zealand
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- June 1, 2006
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- F&P NIVAIRO RT045 NONVENTED HOSPITAL FULL FACE MASK, ANTI-ASPHYXLATION VALVE VERSION
- F&P NIVAIRO RT046 NONVENTED HOSPITAL FULL FACE MASK, STANDARD ELBOW VERSION
- F&P NIVAIRO RT047 VENTED HOSPITAL FULL FACE MASK, ANTI-ASPHYXIATION VALVE VERSION
- F&P NIVAIRO+ RT055 NON-VENTED FULL FACE MASK, ANTI-ASPHYXIATION VALVE VERSION
- F&P NIVAIRO+ RT056 NON-VENTED FULL FACE MASK, STANDARD ELBOW VERSION
- F&P NIVAIRO+ RT057 VENTED FULL FACE MASK, ANT-ASPHYXIATION VALVE VERSION
- NON VENTED MASK
- NON VENTED MASK WITH ANTI-ASPHYXIATION VALVE
- NON-VENTED HOSPITAL UNDER NOSE MASK, ANTI-ASPHYXIATION VALVE VERSION
- NON-VENTED HOSPITAL UNDER NOSE MASK, STANDARD ELBOW VERSION
- VENTED HOSPITAL UNDER NOSE MASK, ANTI-ASPHYXIATION VALVE VERSION
- VENTED MASK
- VENTILATED MASK WITH ANTI-ASPHYXIATION VALVE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.