Medical device licence · 99311 · Class 3
MAXBLEND 2
Yes: licensed in Canada
Licence status Issued (active); first licensed June 15, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99311
- Licence holder
- Maxtec, LlcSalt Lake City, UT, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 15, 2017
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MAX-550E EXTERNAL MEDICAL OXYGEN SENSOR
- MAXBLEND 2+P, HIGH FLOW, FLOWMETER, DISS
- MAXBLEND 2+P, HIGH FLOW, FLOWMETER, NIST
- MAXBLEND 2+P, LOW FLOW, FLOWMETER, DISS
- MAXBLEND 2+P, LOW FLOW, FLOWMETER, NIST
- MAXBLEND2, 0-15 LPM FLOW METER
- MAXBLEND2, 0-3 LPM FLOW METER
- MAXBLEND2, 0-30 LPM FLOW METER
- MAXBLEND2, 0-70 LPM FLOW METER
- MAXBLEND2/MAXO2ME POWER SUPPLY
- POWER SUPPLY
- PRESSURE MONITORING LINE WITH MOISTURE CONTROL TUBING
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.