Medical device licence · 105753 · Class 3
TRILOGY EV300
Yes: licensed in Canada
Licence status Issued (active); first licensed January 25, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 105753
- Licence holder
- Respironics Inc.Murrysville, PA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 25, 2021
- Devices covered
- 25
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AIR INLET FOAM FILTER
- BACTERIAL/VIRAL FILTER
- CABLE, 12/24V BATTERY, WITH CAR ADAPTOR
- CABLE, 12/24V BATTERY, WITH TERMINALS
- CABLE, ISOLATED, USB TO RJ45
- CIRCUIT, DISPOSABLE, NON-HEATED, ACTIVE
- CIRCUIT, DISPOSABLE, NON-HEATED, PASSIVE
- DISPOSABLE ACTIVE EXHALATION VALVE
- DUAL LIMB ACTIVE EXHALATION VALVE
- EXTERNAL FLOW SENSOR ASSEMBLY ADULT/PEDIATRIC
- EXTERNAL FLOW SENSOR ASSEMBLY, PEDIATRIC/INFANT
- EXTERNAL PULSE OXIMETER (NONIN XPOD)
- FIO2 SENSOR ASSEMBLY
- PARTICULATE FILTER
- POWER CORD C7
- REMOTE ALARM INTERNATIONAL
- RJ9 TO 1/4 INCH NURSE CALL ADAPTER CABLE, ALARM CLOSE
- RJ9 TO 1/4 INCH NURSE CALL ADAPTER CABLE, ALARM OPEN
- TRILOGY EV300
- TRILOGY EVO DETACHABLE BATTERY PACK
- TRILOGY EVO INTERNAL BATTERY PACK
- TRILOGY NURSE CALL RJ9 ADAPTER CABLE ASSEMBLY
- USB TO CO2 MONITOR CABLE
- USB TO DB9 CONNECTION CABLE
- WHISPER SWIVEL II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.