Medical device licence · 104588 · Class 3
GEM PREMIER CHEMSTAT
Yes: licensed in Canada
Licence status Issued (active); first licensed April 30, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104588
- Licence holder
- Instrumentation Laboratory Co.Bedford, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 30, 2020
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CHEMSTAT HEMATOCRIT EVALUATOR
- CHEMSTAT SYSTEM EVALUATOR
- GEM CHEMSTAT CVP1
- GEM CHEMSTAT CVP2
- GEM CHEMSTAT CVP3
- GEM CHEMSTAT CVP4
- GEM PREMIER CHEMSTAT
- GEM PREMIER CHEMSTAT PAK NA+, K+, CA++, CI-, GLU, CREA, BUN, TCO2, HCT
- GEM PREMIER CHEMSTAT PAK NA+, K+, CA++, CI-, GLU, CREA, BUN, TCO2, HCT, LAC, PH, PCO2
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.