Medical device licence · 4635 · Class 2
INTRAVENOUS ADMINISTRATION SETS (BURETTE SETS)
Yes: licensed in Canada
Licence status Issued (active); first licensed September 13, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 4635
- Licence holder
- Icu Medical Inc.Dublin, OH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- September 13, 1999
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 150 ML BURETTE SET WITH FLOAT VALVE, PREPIERCED INJECTION SITE, MICRODRIP, PREPIERCED Y-SITE, 78 INCH, NON-DEHP
- 150 ML BURETTE SET, CLAVE INJECTION SITE, 18 INCH, NON-DEHP
- 150 ML BURETTE SET, PREPIERCED INJECTION SITE, 18 INCH, NON-DEHP
- BURETTE SET CONVERTIBLE PIERCING PIN
- BURETTE SET, CLAVE Y-SITE
- LATEX-FREE, PRIMARY SYMBIQ SOLUSET, BURETTE SET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.