Medical device licence · 14302 · Class 2
SARNS TEMPERATURE CONTROL DEVICE
No longer licensed: cancelled
Licence status Cancelled; first licensed November 16, 1999; ended March 19, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 14302
- Licence holder
- Terumo Cardiovascular Systems CorporationTustin, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- November 16, 1999
- Ended
- March 19, 2019
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SARNS TEMPERATURE CONTROL MODULE (TCM II)
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 “sarns”. A notice may cover another product or only some lots: read it to see what it covers.
- Sarns TCM II Cooling and Heating Systems (2018-04-06)May 25, 2018 · Medical devices · Medical devices · Type II
- SARNS Modular Perfusion System 8000March 31, 2017 · Medical devices · Type III
- Sarns Temperature Control Module (TCM II) (2016-07-06)July 22, 2016 · Medical devices · Medical devices · Type III
- Sarns Centrifugal Pump (2014-04-18)August 22, 2014 · Medical devices · Medical devices · Type III
- Sarns Cannulae and Tenderflow Pediatric Venous Return Catheters (2014-07-25)August 8, 2014 · Medical devices · Medical devices · Type II
- Sarns Dual-Stage Malleable Venous Return Catheter (2014-03-07)April 15, 2014 · Medical devices · Medical devices · Type III
- Sarns Soft Flow Aortic Cannula, Angled Tip (2013-10-28)November 29, 2013 · Medical devices · Medical devices · Type I
- Sarns Cannulas - Flexible Arterial and High-Flow Aortic Arch (January 14, 2013)February 18, 2013 · Medical devices · Medical devices · Type II
- Sarns Centrifugal SystemJanuary 7, 2013 · Medical devices · Type II
- Sarns Soft-Flow Aortic CannulaeDecember 24, 2012 · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.