Medical device licence · 94411 · Class 2
EPIDURAL MINIPACKS
Yes: licensed in Canada
Licence status Issued (active); first licensed December 17, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 94411
- Licence holder
- Icu Medical Inc.Dublin, OH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- December 17, 2014
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EPIDURAL MINIPACKS
- PORTEX EPIDURAL MINIPACK WITH NRFIT CONNECTOR SYSTEM 1
- PORTEX EPIDURAL MINIPACK WITH NRFIT CONNECTOR SYSTEM 1, CLEAR CATHETER, CLOSED END, 3 LATERAL EYES
- PORTEX EPIDURAL MINIPACK WITH NRFIT CONNECTOR SYSTEM 2, CLEAR CATHETER, CLOSED END, 3 LATERAL EYES
- PORTEX NRFIT SINGLE SHOT EPIDURAL PACK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.