Medical device licence · 104395 · Class 2
O2 MAX SYSTEMS
Yes: licensed in Canada
Licence status Issued (active); first licensed March 2, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104395
- Licence holder
- PulmodyneIndianapolis, IN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- March 2, 2020
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- O2 MAX FIXED SYSTEM WITH BITRAC ED MASK & O2 CPAP VALVE (ADULT)
- O2 MAX TRIO SYSTEM BITRAC ED MASK, O2 CPAP VALVE (ADULT)
- O2 MAX VARIABLE SYSTEM WITH BITRAC ED MASK & O2 CPAP VALVE (ADULT)
- O2-MAX FIXED SYSTEM WITH NEBULIZER BITRAC ED MASK O2-MAX (GUARD) FILTER O2-CPAP VALVE
- O2-MAX FIXED SYSTEM WITH NEBULIZER BITRAC ED MASK O2-MAX (GUARD) FILTER O2-CPAP VALVE OHMEDA CONNECTOR
- O2-MAX TRIO SYSTEM WITH NEBULIZER BITRAC ED MASK 3-SET 02-CPAP VALVE
- O2-MAX TRIO SYSTEM WITH NEBULIZER BITRAC ED MASK 3-SET 02-CPAP VALVE OHMEDA CONNECTOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.