Medical device licence · 74287 · Class 2
FACE MASKS
Yes: licensed in Canada
Licence status Issued (active); first licensed June 20, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 74287
- Licence holder
- Sunmed Holdings, LlcGrand Rapids, MI, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- June 20, 2007
- Devices covered
- 35
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADULT AEROSOL MASK (NONVENTED)
- ADULT AEROSOL MASK, W/SINGLE VENT
- ADULT FACE TENT
- ADULT TRACH MASK
- ANESTHESIA MASK, PEDIATRIC, SERIES 800, W/HOOK RING
- ANESTHESIA MASK, SERIES 800
- ANESTHESIA MASK, SERIES 900, INFANT W/HOOK RING
- ANESTHESIA MASK, SERIES 900, LARGE ADULT W/HOOK RING
- ANESTHESIA MASK, SERIES 900, NEONATAL W/HOOK RING
- ANESTHESIA MASK, SERIES 900,PEDIATRIC W/HOOK RING
- ELONGATED AEROSOL MASKS
- ELONGATED FACE MASKS
- INFANT AEROSOL MASKS
- MASK ADULT, RIBBED CUSHION
- MASK, INFANT, RIBBED CUSHION
- MASK, NEONATAL, RIBBED CUSHION
- MASK, TODDLER, RIBBED CUSHION
- PEDIATRIC AEROSOL CHARACTER MASK
- PEDIATRIC AEROSOL MASK, W/SINGLE VENT
- PEDIATRIC, TRACHEOSTOMY MASK
- SERIES 700 FACE MASK, ADULT W/HOOK RING
- SERIES 700 FACE MASK, INFANT
- SERIES 700 FACE MASK, NEONATAL
- SERIES 700 FACE MASK, PEDIATRIC W/HOOK RING
- SERIES 800 FACE MASK, ADULT W/HOOK RING
- SERIES 800 FACE MASK, INFANT
- SERIES 800 FACE MASK, NEONATAL
- SERIES 800 FACE MASK, PEDIATRIC W/HOOK RING
- SERIES 810 FACE MASK, ADULT W/HOOK RING
- SERIES 810 FACE MASK, ADULT W/HOOK RING AND VALVE
- SERIES 810 FACE MASK, ADULT W/VALVE
- SERIES 810 FACE MASK, INFANT W/VALVES
- SERIES 810 FACE MASK, NEONATE W/VALVE
- SERIES 810 FACE MASK, PAEDIATRIC W/HOOK AND VALVE
- SUPER SPIKE AEROSOL MASK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.