Medical device licence · 7643 · Class 3
ACT II SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 12, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 7643
- Licence holder
- Medtronic Inc.Minneapolis, MN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 12, 1999
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACT II (AUTOMATED COAGULATION TIMER II)
- ACT II SYSTEM - TEMPERATURE PROBE
- ACTTRAC ELECTRONIC CONTROL
- CALCIUM CHORIDE SOLUTION 0.10 M
- CLOTTRAC COAGULATION CONTROLS
- CLOTTRAC HR CONTROL HIGH RANGE CITRATED WHOLE BLOOD COAGULATION CONTROL
- CLOTTRAC HTC CONTROL HEPARINIZED WHOLE BLOOD COAGULATION CONTROL
- GENERAL PURPOSE CLOTTING CARTRIDGE 0.02 MOLAR CACL2
- HIGH RANGE HEPARINASE TEST CARTRIDGES
- HR-ACT HIGH RANGE HEPARIN (ACTIVE CLOTTING TIME CARTRIDGE FOR BLOOD COAGULA
- LR-ACT LOW RANGE HEPARIN ACTIVATED CLOTTING TIME CARTRIDGE
- PT PROTHROMBIN TIME (FOR USE IN PROTHROMBIN TIME DETERMINATIONS )
- RECALCIFIED ACTIVATED CLOTTING TIME CARTRIDGES
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.