Medical device licence · 104193 · Class 2
HEAT/MOISTURE EXCHANGER
Yes: licensed in Canada
Licence status Issued (active); first licensed January 21, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104193
- Licence holder
- PulmodyneIndianapolis, IN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- January 21, 2020
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AERO-SAT 1 STRAIGHT HEAT MOISTURE EXCHANGER
- AERO-SAT 1 STRAIGHT W/PORT HEAT MOISTURE EXCHANGER WITH PORT
- AERO-SAT 2 ANGLED HEAT MOISTURE EXCHANGER WITH PORT
- AERO-SAT 2 STRAIGHT HEAT MOISTURE EXCHANGER
- AERO-SAT MICRO +3.0 HEAT MOISTURE EXCHANGER
- AERO-SAT MICRO +3.5 HEAT MOISTURE EXCHANGER
- AERO-SAT MINI HEAT MOISTURE EXCHANGER
- AERO-T HEAT MOISTURE EXCHANGER
- AERO-T+ HEAT MOISTURE EXCHANGER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.