Medical device licence · 104609 · Class 3
BIPAP A40 EFL
Yes: licensed in Canada
Licence status Issued (active); first licensed May 14, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104609
- Licence holder
- Respironics Inc.Murrysville, PA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 14, 2020
- Devices covered
- 23
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- A-SERIES POWER SUPPLY
- A40 PRO/EFL, HEATED HUMIDIFIER
- A40 PRO/EFL, HEATED TUBE HUMIDIFIER
- BIPAP A40 EFL CA
- BIPAP A40 EFL WI/HEATED TUBE HUMIDIFIER
- DC BATTERY ADAPTER CABLE
- DETACHABLE BATTERY MODULE
- DETACHABLE BATTERY PACK
- DREAMSTATION TRAVEL SUPPLY
- FILTER, BACTERIAL
- HEATED TUBE (DREAMSTATION)
- LI-ION BATTERY, BIPAP DEVICE CABLE
- LI-ION BATTERY, TRILOGY CABLE
- POLLEN (FOAM) FILTER
- POWER CORD C7
- PRESSURE RELIEF VALVE
- RESPIRATORY LI-ION BATTERY KIT
- SHIELDED DC POWER CORD
- SYSTEMONE PERFORMANCE TUBING
- TUBE (DREAMSTATION)
- TUBING HIGH-TEMP
- ULTRAFINE FILTER
- WHISPER SWIVEL II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.