Medical device licence · 296 · Class 3
AESTIVA/5 ANAESTHESIA MACHINE
Yes: licensed in Canada
Licence status Issued (active); first licensed November 18, 1998. It is in Health Canada’s list of active licences.
- Licence number
- 296
- Licence holder
- Datex-Ohmeda, Inc.Madison, WI, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- November 18, 1998
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AESTIVA/5 ANAESTHESIA MACHINE
- AESTIVA/5 ANAESTHESIA MACHINE - AC INLET/OUTLET
- AESTIVA/5 ANAESTHESIA MACHINE - AGSS-ACTIVE
- AESTIVA/5 ANAESTHESIA MACHINE - AGSS-PASSIVE
- AESTIVA/5 ANAESTHESIA MACHINE - BAG ARM
- AESTIVA/5 ANAESTHESIA MACHINE - CANADIAN CONFIGURATION KIT
- AESTIVA/5 ANAESTHESIA MACHINE - DISPLAY MOUNT
- AESTIVA/5 ANAESTHESIA MACHINE - FRAMES
- AESTIVA/5 ANAESTHESIA MACHINE - GAS CYLINDER/PIPELINE
- AESTIVA/5 ANAESTHESIA MACHINE - INTEGRATED SUCTION REGULATOR
- AESTIVA/5 ANAESTHESIA MACHINE - PATIENT BREATHING SYSTEM MODULE
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “aestiva”. A notice may cover another product or only some lots: read it to see what it covers.
- Aestiva/5 MRI System (2019-07-25)August 9, 2019 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.