Medical device licence · 95334 · Class 2
TRACHEOSTOMY KITS
Yes: licensed in Canada
Licence status Issued (active); first licensed June 23, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95334
- Licence holder
- Icu Medical Inc.Dublin, OH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- June 23, 2015
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PORTEX BLUE LINE PERCUTANEOUS DILATION TRACHEOSTOMY KIT
- PORTEX BLUE LINE PERCUTANEOUS SUCTIONAID TRACHEOSTOMY KIT
- PORTEX BLUE LINE PERCUTANEOUS TRACHEOSTOMY KIT
- PORTEX BLUE LINE ULTRA PERCUTANEOUS TRACHEOSTOMY KIT
- PORTEX PERCUTANEOUS TRACHEOSTOMY KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.