Medical device licence · 100227 · Class 3
GEM PREMIER 5000
Yes: licensed in Canada
Licence status Issued (active); first licensed December 18, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 100227
- Licence holder
- Instrumentation Laboratory Co.Bedford, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 18, 2017
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GEM CVP (CALIBRATION VALUATION PRODUCT) 5 TBILI
- GEM PREMIER 5000
- GEM PREMIER 5000 PAK PH, PCO2, PO2, HCT, TBILI, THB, O2HB, COHB, METHB, HHB, SO2
- GEM PREMIER 5000 PAK PH, PCO2, PO2, HCT, THB, O2HB, COHB, METHB, HHB, SO2
- GEM PREMIER 5000 PAK PH, PCO2, PO2, NA+, K+, CL-, CA++, GLUCOSE, LACTATE, HCT, TBILI, THB, O2HB, COHB, METHB, HHB, SO2
- GEM PREMIER 5000 PAK PH, PCO2, PO2, NA+, K+, CL-, CA++, GLUCOSE, LACTATE, HCT, THB, O2HB, COHB, METHB, HHB, SO2
- GEM PREMIER 5000 PAK PH, PCO2, PO2, NA+, K+, CL-, CA++, HCT, TBILI, THB, O2HB, COHB, METHB, HHB, SO2
- GEM PREMIER 5000 PAK PH, PCO2, PO2, NA+, K+, CL-, CA++, HCT, THB, O2HB, COHB, METHB, HHB, SO2
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.