Medical device licence · 61382 · Class 2
AIRSEAL MASKS
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed January 7, 2003; ended October 26, 2010. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 61382
- Licence holder
- Engineered Medical Systems Inc.Indianapolis, IN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- January 7, 2003
- Ended
- October 26, 2010
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADULT AIRSEAL SINGLE PORT PVC MASK
- CHILD AIRSEAL SINGLE PORT PVC MASK
- INFANT AIRSEAL SINGLE PORT PVC MASK
- NEONATAL AIRSEAL SINGLE PORT PVC MASK
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “airseal”. A notice may cover another product or only some lots: read it to see what it covers.
- AirSeal Access Port With Blunt Obturator and AirSeal Access Port With Optical ObturatorJuly 2, 2026 · General and plastic surgery · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.