Medical device licence · 80934 · Class 2
ACTIVE EXHALATION DEVICE
Yes: licensed in Canada
Licence status Issued (active); first licensed October 19, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80934
- Licence holder
- Respironics Inc.Murrysville, PA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- October 19, 2009
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADULT DISPOSABLE ACTIVE EXHALATION HEATED WIRE CIRCUIT
- DISPOSABLE ADULT ACTIVE CIRCUIT, NO WATER TRAP
- DISPOSABLE PEDIATRIC ACTIVE CIRCUIT, WITH WATER TRAP
- PEDIATRIC DISPOSABLE ACTIVE EXHALATION HEATED WIRE CIRCUIT
- TRILOGY ACTIVE FLOW EXHALATION CIRCUIT, ADULT
- TRILOGY ACTIVE FLOW EXHALATION CIRCUIT, PEDIATRIC
- TRILOGY ACTIVE WITH PAP EXHALATION CIRCUIT, ADULT
- TRILOGY ACTIVE WITH PAP EXHALATION CIRCUIT, PEDIATRIC
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.