Medical device licence · 96384 · Class 2
CELERITY PICC TIP CONFIRMATION SYSTEM WITH NAVIGATION
Yes: licensed in Canada
Licence status Issued (active); first licensed January 29, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 96384
- Licence holder
- Angiodynamics, Inc. Also D.B.A. As Navilyst Medical , Inc.Marlborough, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 29, 2016
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 7.2V LI ION BATTERY ACCESSORY
- CELERITY PICC TIP CONFIRMATION SYSTEM WITH NAVIGATION
- ECG CABLE ACCESSORY PACK
- ECG ELECTRODES AND 3 - PREP PADS
- ECG SNAP LEAD SET
- NAVIGATION PATIENT T-BAR ACCESSORY
- NAVIGATION STYLET ACCESSORY PACK
- POWER SUPPLY CORD ACCESSORY
- REMOTE CONTROL CABLE ACCESSORY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.