Medical device licence · 97775 · Class 2
ALTRIX PRECISION TEMPERATURE MANAGEMENT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 10, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97775
- Licence holder
- Stryker MedicalPortage, MI, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 10, 2016
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALTRIX
- ALTRIX TEMPERATURE MANAGEMENT HOSE
- ALTRIX TEMPERATURE MANAGEMENT WRAPS
- INSULATED CLIK-TITE HOSE
- INSULATED COLDER CONNECTOR HOSE
- REUSABLE ADAPTER CABLE
- REUSABLE PATIENT TEMPERATURE OUTPUT CABLE
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 “altrix”. A notice may cover another product or only some lots: read it to see what it covers.
- ALTRIX PRECISION TEMPERATURE MANAGEMENT SYSTEM (2020-11-12)November 27, 2020 · Medical devices · Medical devices · Type II
- Altrix Precision Temperature Management System (2018-09-04)September 28, 2018 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.