Medical device licence · 83213 · Class 2
PASSIVE EXHALATION DEVICE
Yes: licensed in Canada
Licence status Issued (active); first licensed June 29, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 83213
- Licence holder
- Respironics Inc.Murrysville, PA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- June 29, 2010
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADULT DISPOSABLE PASSIVE EXHALATION HEATED WIRE CIRCUIT
- DISPOSABLE ADULT PASSIVE CIRCUIT, NO WATER TRAP
- DISPOSABLE PEDIATRIC PASSIVE CIRCUIT WITH WATER TRAP
- PEDIATRIC DISPOSABLE PASSIVE EXHALATION HEATED WIRE CIRCUIT
- TRILOGY INVASIVE PASSIVE DISPOSABLE EXHALATION CIRCUIT, ADULT
- TRILOGY INVASIVE PASSIVE DISPOSABLE EXHALATION CIRCUIT, PEDIATRIC
- TRILOGY NON-INVASIVE PASSIVE DISPOSABLE EXHALATION CIRCUIT, ADULT
- TRILOGY PASSIVE EXHALATION CIRCUIT, ADULT
- TRILOGY PASSIVE EXHALATION CIRCUIT, PEDIATRIC
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.