Medical device licence · 21999 · Class 3
NXSTAGE SYSTEM ONE
Yes: licensed in Canada
Licence status Issued (active); first licensed July 18, 2000. It is in Health Canada’s list of active licences.
- Licence number
- 21999
- Licence holder
- Nxstage Medical, Inc.Lawrence, Massachusetts, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 18, 2000
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- NXSTAGE CARTRIDGE
- NXSTAGE NXVIEW
- NXSTAGE SYSTEM ONE - CARTRIDGE EXPRESS
- NXSTAGE SYSTEM ONE - CYCLER (ACUTE APPLICATION)
- NXSTAGE SYSTEM ONE - CYCLER (ACUTE APPLICATION)
- NXSTAGE SYSTEM ONE - CYCLER (CHRONIC APPLICATION)
- NXSTAGE SYSTEM ONE - CYCLER BASE AND FLUID DETECTION SENSOR
- NXSTAGE SYSTEM ONE - EXPRESS FLUID WARMER
- NXSTAGE SYSTEM ONE - NXSTAGE CONNECTED HEALTH
- NXSTAGE SYSTEM ONE - PUREFLOW SL
- NXSTAGE SYSTEM ONE - PUREFLOW SL PURIFICATION PACK (PAK)
- NXSTAGE SYSTEM ONE - STAND
- NXSTAGE SYSTEM ONE - STANDARD CARTRIDGE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.