Medical device licence · 13015 · Class 2
INTRAVENOUS ADMINSTRATION SETS (PRIMARY SETS)
Yes: licensed in Canada
Licence status Issued (active); first licensed October 12, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 13015
- Licence holder
- Icu Medical Inc.Dublin, OH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- October 12, 1999
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LATEX-FREE PRIMARY SYMBIQ PUMP SET, NON-DEHP
- LATEX-FREE PRIMARY SYMBIQ SET, CONVERTIBLE P.P 15 MICRON FILTER AND OPTION-LOK
- MICROBORE, SYMBIQ SYRINGE SET, CLAVE SYRINGE HOLDER, 1.2 MICRON FILTER, CLAVE Y-SITE, 84 INCH, NON-DEHP
- NONVENTED MICRODRIP PIGGYBACK PRIMARY SET
- NONVENTED PRIMARY I.V. SET
- PRIMARY I.V. SET VENTED WITH BACKCHECK VALVE
- PRIMARY SET, MICRODRIP, PREPIERCED Y-SITE, NON-DEHP
- PRIMARY SYMBIQ SET PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, NON-DEHP
- SYMBIQ POLYETHYLENE TUBING, CONVERTIBLE PIN WITH OPTION LOCK, LATEX FREE
- Y-TYPE PRIMARY I.V. SET WITH CAIR CLAMP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.