Medical device licence · 14921 · Class 3
BIO-CONSOLE
Yes: licensed in Canada
Licence status Issued (active); first licensed January 21, 2000. It is in Health Canada’s list of active licences.
- Licence number
- 14921
- Licence holder
- Medtronic Inc.Minneapolis, MN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- January 21, 2000
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AUTOCLAMP AIR SUPPLY LINE
- AUTOCLAMP INTERFACE CABLE
- AUTOCLAMP INTERFACE MODULE
- AUTOCLAMP SYSTEM KIT
- BIO-CONSOLE DRIVE UNIT (540)
- BIO-CONSOLE DRIVE UNIT (550)
- BIO-CONSOLE DRIVE UNIT (560)
- BUBBLE DETECTOR CABLE - ADULT
- BUBBLE DETECTOR CABLE - PEDIATRIC
- LEVEL SENSOR
- REMOTE TUBE CLAMP
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 “bio-console”. A notice may cover another product or only some lots: read it to see what it covers.
- Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console (2021-03-05)February 8, 2022 · Cardiovascular · Manufacturing defect · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.