Medical device licence · 94814 · Class 2
PHARMGUARD SYSTEM INFUSION MANAGEMENT SOFTWARE
Yes: licensed in Canada
Licence status Issued (active); first licensed April 30, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 94814
- Licence holder
- Icu Medical Inc.Dublin, OH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- April 30, 2015
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MEDFUSION MODEL 4000 PUMP DEVICE-SPECIFIC REPORTS AND METADATA FOR PHARMGUARD SERVER
- MEDFUSION STANDARD CONFIGURATION
- MEDFUSION STANDARD SYRINGES, SERIES 2
- MONOJECT ENFIT, PHARMGUARD SUPPORTED SYRINGES (PSS)
- PHARMGUARD DEVICE REPORTS SOFTWARE 2.5
- PHARMGUARD DEVICE REPORTS SOFTWARE 2.6
- PHARMGUARD SUPPORTED SYRINGES (PSS) SYRINGE CONFIGURATION DATA
- PHARMGUARD TOOLBOX
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.