Medical device licence · 15329 · Class 2
GEMSTAR PUMP SETS
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed December 16, 1999; ended October 21, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 15329
- 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 16, 1999
- Ended
- October 21, 2019
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GEMSTAR PUMP SET
- LATEX-FREE, NON-DEHP, GEMSTAR SET WITH INJECTOR CAPPED Y-EXTENSION WITH BACKCHECK VALVE
- LIFESHIELD, PRIMARY MICROBORE GEMSTAR SPLIT SET, FILTER, PREPIERCED Y-SITE, ATTACHED PAV
- MICROBORE GEMSTAR SET
- MICROBORE GEMSTAR SET, PROXIMAL FEMALE ADAPTER Y-EXTENSION WITH BACKCHECK VALVE
- MICROBORE GEMSTAR SPLIT SET NON-VENTED, CAPPED Y-EXTENSION WITH BACKCHECK VALVE INTEGRAL PAV, NON-DEHP
- PRIMARY GEMSTAR SET, PIGGYBACK WITH BACKCHECK VALVE
- PRIMARY MICROBORE GEMSTAR SET, ATTACHED PAV
- PRIMARY MICROBORE GEMSTAR SPLIT SET, INTEGRAL PAV
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “gemstar”. A notice may cover another product or only some lots: read it to see what it covers.
- Gemstar Pumps (2014-02-04)March 25, 2014 · Medical devices · Medical devices · Type II
- Gemstar Docking Station (2012-12-08)March 18, 2014 · Medical devices · Type II
- GemStar Bolus Cord - Urgent - Potential Risk Due to Device Failure - For Health ProfessionalsApril 4, 2012 · Medical devices
- Gemstar Bolus CordApril 2, 2012 · Medical devices · Type II
- Gemstar Pump Sets - Recall - For Health ProfessionalsSeptember 8, 2010 · Medical devices
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.