Medical device licence · 104448 · Class 2
NASAL MASKS
Yes: licensed in Canada
Licence status Issued (active); first licensed March 16, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104448
- Licence holder
- PulmodyneIndianapolis, IN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- March 16, 2020
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BITRAC HC NASAL MASK (ADULT)
- BITRAC NASAL MASK (ADULT)
- BITRAC SE SELECT NASAL MASK (ADULT)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.