Medical device licence · 98781 · Class 2
MASK KITS
Yes: licensed in Canada
Licence status Issued (active); first licensed March 8, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 98781
- Licence holder
- Intersurgical Ltd.East Syracuse, NY, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- March 8, 2017
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ECOLITE, ADULT, VENTURI MASK KIT
- INTERSURGICAL ECOLITE, ADULT, OXYGEN MASK WITH 24% VENTURI VALVE
- INTERSURGICAL ECOLITE, ADULT, OXYGEN MASK, WITH VENTURI VALVE, AND TUBE
- INTERSURGICAL ECOLITE, PAEDIATRIC, VENTURI MASK KIT
- MULTIOX, INTERSURGICAL ECOLITE, ADULT, ADJUSTABLE VENTURI MASK KIT WITH TUBE
- MULTIOX, INTERSURGICAL ECOLITE, PAEDIATRIC, ADJUSTABLE VENTURI MASK KIT WITH TUBE
- OXYGEN RECOVERY T-KIT
- SILENTE O2 VENTURI
- SILENTE, INTERSURGICAL ECOLITE, ADULT, ADJUSTABLE VENTURI MASK KIT AND TUBE WITH UNIVERSAL CONNECTOR
- SILENTE, INTERSURGICAL ECOLITE, ADULT, ADJUSTABLE VENTURI MASK KIT WITH TUBE
- SILENTE, INTERSURGICAL ECOLITE, PAEDIATRIC, ADJUSTABLE VENTURI MASK KIT WITH TUBE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.