Medical device licence · 71393 · Class 2
NEBULIZER SETS
Yes: licensed in Canada
Licence status Issued (active); first licensed May 19, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 71393
- Licence holder
- Sunmed Holdings, LlcGrand Rapids, MI, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- May 19, 2006
- Devices covered
- 44
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AERO2 DC HEART, ADULT AERO MASK WITH O2 ADAPTOR, AEROSOL BAG
- CIRCULAIRE ADULT HOMECARE MODEL
- CIRCULAIRE ADULT HOSPITAL MODEL
- CIRCULAIRE ADULT HOSPITAL MODEL WITH EXPIRATORY SIDE FILTER
- CIRCULAIRE II AEROSOL DRUG DELIVERY SYSTEM
- CIRCULAIRE II HYBRID
- CIRCULAIRE PEDIATRIC HOSPITAL MODEL
- CIRCULAIRE PEP DEVICE WITH MOUTHPIECE
- HEART
- HEART DIRECT CONNECT, ADULT AEROSOL MASK
- HEART DIRECT CONNECT, PEDIATRIC AEROSOL MASK
- HEART LARGE VOLUME CONTINOUS NEBULIZATION KIT, DIRECT CONNECT ADULT
- HEART LARGE VOLUME CONTINUOUS NEBULIZATION KIT, ADULT
- HEART LARGE VOLUME CONTINUOUS NEBULIZATION KIT, DIRECT CONNECT PEDIATRIC
- INFANT NEBULIZER KIT - INCLUDES NEBULIZER EXTENSION
- IV HEART
- IV HEART, ADULT AEROSOL MASK
- IV HEART, PEDIATRIC AEROSOL MASK
- MINIHEART LO-FLO
- MINIHEART, HI-FLO
- MINIHEART, HI-FLO, ADULT MASK
- MINIHEART, HI-FLO, PEDIATRIC MASK
- MINIHEART, LO-FLO WITH EXTENSION SET
- MINIHEART, LO-FLO, SUPPLY TUBING
- PEDI-NEB NASAL NEBULIZER
- UNIHEART
- UNIHEART, ADULT AEROSOL MASK
- UNIHEART, PEDIATRIC MASK
- UNOMIST NEBULIZER MASK KIT ADULT
- UNOMIST NEBULIZER MASK KIT PEDIATRIC
- UNOMIST SMALL VOLUME NEBULIZER
- VIX ON DEMAND PATIENT ACTUATED NEBULIZER
- VIXONE INFANT EXTENSION AND FLEX ADAPTOR WITH THAYER VALVE
- VIXONE INFANT INLINE KIT
- VIXONE NEBULIZER
- VIXONE NEBULIZER (INDIVIDUALLY BAGGED)
- VIXONE NEBULIZER (UNASSEMBLED) WITH MOUTHPIECE
- VIXONE NEBULIZER WITH MOUTHPIECE, KINK RESISTANT TUBING
- VIXONE NEBULIZER, KINK RESISTANT TUBING
- VIXONE NEBULIZER, PACIFIER, KINK RESISTANT OXYGEN TUBING
- VIXONE NEBULIZER, TUBING AND ADULT MASK
- VIXONE NEBULIZER, TUBING AND PEDIATRIC MASK
- VIXONE REUSABLE NEBULIZER KIT
- VIXONE SMALL VOLUME NEBULIZER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.