Medical device licence · 72576 · Class 3
GEM PREMIER 4000 SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 25, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 72576
- Licence holder
- Instrumentation Laboratory Co.Bedford, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 25, 2006
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GEM PREMIER 4000 SYSTEM - CALIBRATORS
- GEM PREMIER 4000 SYSTEM - INSTRUMENT
- GEM PREMIER 4000 SYSTEM - PAK PH, PCO2, PO2, HCT, THB, O2HB, COHB, METHB,
- GEM PREMIER 4000 SYSTEM - PAK PH, PCO2, PO2, NA+, K+, CA++, CL-, GLU, THB,
- GEM PREMIER 4000 SYSTEM - PAK PH, PCO2, PO2, NA+, K+, CA++, CL-, HCT, THB,
- GEM PREMIER 4000 SYSTEM- PAK BG/HCT/LTYES/TBILI/CO-OX
- GEM PREMIER 4000 SYSTEM- PAK BG/HCT/LYTES/GLU/LAC/TBILI/CO-OX
- GEM PREMIER 4000 SYSTEM- PAK BG/HCT/TBILI/CO-OX
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.