Medical device licence · 3850 · Class 2
TRACHEOSTOMY TUBES - SILICONE
Yes: licensed in Canada
Licence status Issued (active); first licensed June 2, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 3850
- Licence holder
- Icu Medical Inc.Dublin, OH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- June 2, 1999
- Devices covered
- 19
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FIXED FLANGE HYPERFLEX EXTRA LENGTH CUFFED TRACHEOSTOMY TUBE - SILICONE
- FIXED FLANGE HYPERFLEX EXTRA LENGTH UNCUFFED TRACHEOSTOMY TUBE - SILICONE
- NEONATAL TRACHEOSTOMY TUBE, CUFFLESS
- NEONATAL TRACHEOSTOMY TUBE, FLEXTEND CUFFLESS
- NEONATAL TRACHEOSTOMY TUBE, MID RANGE AIRE-CUF
- PEDIATRIC TRACHEOSTOMY TUBE, CUFFLESS
- PEDIATRIC TRACHEOSTOMY TUBE, MID RANGE AIRE-CUF
- PEDIATRIC/NEONATAL TRACHEOSTOMY TUBES
- TRACHEOSTOMA VENT
- TRACHEOSTOMY TUBES ADJUSTABLE HYPERFLEX TTS, SILICONE, ADULT
- TRACHEOSTOMY TUBES CUFFLESS, SILICONE ADULT
- TRACHEOSTOMY TUBES CUFFLESS, SILICONE, SLEEP APNEA
- TRACHEOSTOMY TUBES CUFFLESS, WIRE REINFORCED SILICONE, ADJUSTABLE HYPERFLEX
- TRACHEOSTOMY TUBES FLEX-TEND, PEDIATRIC, WIRE REINFORCED SILICONE
- TRACHEOSTOMY TUBES FOME-CUF, SILICONE, ADULT
- TRACHEOSTOMY TUBES FOME-CUF, WIRE REINFORCED SILICONE, WITH TRACHEOSTOMA SE
- TRACHEOSTOMY TUBES MID RANGE AIRE-CUF, WITH TALK ATTACHMENTS, ADULT
- TRACHEOSTOMY TUBES MID-RANGE AIRE-CUF, SILICONE, ADULT
- TRACHEOSTOMY TUBES TIGHT TO SHAFT (TTS) AIRE-CUF SILICONE ADULT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.