Medical device licence · 80206 · Class 2
VENTILATOR CIRCUITS
Yes: licensed in Canada
Licence status Issued (active); first licensed July 14, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80206
- Licence holder
- Icu Medical Inc.Dublin, OH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- July 14, 2009
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DUAL LIMB CIRCUIT FOR PNEUPAC BABYPAC VENTILATORS
- PNEUPAC PARAPAC PLUS DISPOSABLE CPAP CIRCUIT WITH ADULT MASK
- SINGLE LIMB CIRC. PNEUPAC DEMAND TYPE VEN. W/PEEP VALVE & PRES. MON. LINE
- SINGLE LIMB CIRCUIT FOR PNEUPAC DEMAND TYPE VENTILATORS
- SINGLE LIMB CIRCUIT FOR PNEUPAC DEMAND TYPE VENTILATORS, WITH PEEP VALVE
- SINGLE LIMB CIRCUIT FOR PNEUPAC NON-DEMAND TYPE VENTILATORS
- SINGLE LIMB CIRCUIT FOR PNEUPAC NON-DEMAND TYPE VENTILATORS, W/PEEP VALVE
- SINGLE LIMB CIRCUIT FOR PNEUPAC PARAPAC PLUS VENTILATORS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.