Medical device licence · 104705 · Class 2
FACE MASKS
Yes: licensed in Canada
Licence status Issued (active); first licensed June 1, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104705
- Licence holder
- PulmodyneIndianapolis, IN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- June 1, 2020
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BITRAC ED FULL FACE MASK WITH HEAD STRAP (ADULT)
- BITRAC FULL FACE MASK (ADULT)
- BITRAC HC FULL FACE MASK (ADULT)
- BITRAC MAXSHIELD ED MASK AND HEAD STRAP (ADULT)
- BITRAC MAXSHIELD SHIELD MASK (ADULT)
- BITRAC SE FULL FACE MASK (ADULT)
- BITRAC SE MAXSHIELD SHIELD MASK (ADULT)
- BITRAC SE SELECT FULL FACE MASK (ADULT)
- BITRAC SE SELECT MAXSHIELD MASK (ADULT)
- BITRAC SELECT FULL FACE MASK (ADULT)
- BITRAC SELECT MAXSHIELD MASK
- BITRAC SELECT MAXSHIELD MASK ANTI-ASPHYXIA WITH LEAK ELBOW
- BITRAC SELECT NIV FULL FACE MASK (ADULT)
- BITRAC SELECT PEDIATRIC MAXSHIELD MASK
- BITRAC SHIELD ED MASK AND HEADSTRAP (ADULT)
- BITRAC SHIELD MASK (ADULT)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.