Medical device licence · 78852 · Class 2
OXYGEN MASKS
Yes: licensed in Canada
Licence status Issued (active); first licensed January 16, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 78852
- Licence holder
- Sunmed Holdings, LlcGrand Rapids, MI, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- January 16, 2009
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADULT HIGH CONCENTRATION NON-REBREATHER WITH SUPPLY TUBING
- ADULT HIGH CONCENTRATION PARTIAL NON-REBREATHER WITH SUPPLY TUBING
- ADULT MEDIUM CONCENTRATION WITH SUPPLY TUBING
- ADULT OXYGEN MASK, HIGH CONCENTRATION
- INFANT HIGH CONCENTRATION PARTIAL NON-REBREATHER WITH SUPPLY TUBING
- INFANT MEDIUM CONCENTRATION WITH SUPPLY TUBING
- INFANT OXYGEN MASK, HIGH CONCENTRATION
- PEDIATRIC HIGH CONCENTRATION NON-REBREATHER WITH SUPPLY TUBING
- PEDIATRIC HIGH CONCENTRATION PARTIAL NON-REBREATHER WITH SUPPLY TUBING
- PEDIATRIC MEDIUM CONCENTRATION WITH SUPPLY TUBING
- PEDIATRIC OXYGEN MASK, HIGH CONCENTRATION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.