Medical device licence · 71574 · Class 2
O2 CANNULA SETS
Yes: licensed in Canada
Licence status Issued (active); first licensed June 12, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 71574
- Licence holder
- Sunmed Holdings, LlcGrand Rapids, MI, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- June 12, 2006
- Devices covered
- 44
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADULT CANNULA
- ADULT DEMAND CANNULA SET
- ADULT NASAL CANNULA O2/CO2 SAMPLING LINE W/MALE LUER
- ADULT NASAL CANNULA W/KROT
- ADULT NASAL CANNULA W/KROT AND THREADED NUT
- ADULT NASAL CANNULA, W/SHORE TUBING
- ADULT O2/CO2 MASK, W/SWIVEL GSE
- APNEALINK NASAL CANNULA
- BIFLO MASK WITH 14' KINK RESISTANT TUBING
- BIFLO NASAL MASK PEDIATRIC WITH KINK RESISTANT TUBING
- BIFLO NASAL MASK W/KINK TUBING
- BIFLO NASAL MASK W/KINK TUBING AND THREADED NUT
- BIFLO NASAL MASKS ADULT WITH KINK RESISTANT TUBING
- BUBBLE HUMIDIFIER
- C02/02 NASAL CANNULA
- C02/02 ORAL/NASAL CANNULA
- CANNULA ADULT HIGH FLOW WITH KROT
- CANNULA, ADULT, HIGH FLOW W/TUBING
- CANNULA, ADULT, NON-INTEGRAL W/TUBING BULK VAPOTHERM
- CANNULA, ADULT, W/KROT AND EARMATES
- CO2/O2 NASAL CANNULA W/ REFLECTIVE LUER, GAS SAMPLING TEE AND TUBING
- COMFORT PLUS SOFT TIP CANNULAS - ADULT HARNESS ONLY WITH CONNECTOR
- COMFORT PLUS SOFT TIP CANNULAS - ADULT WITH KINK RESISTANT TUBING
- COMFORT PLUS SOFT TIP CANNULAS - INFANT WITH KINK RESISTANT TUBING
- COMFORT PLUS SOFT TIP CANNULAS - NEONATAL WITH KINK RESISTANT TUBING
- COMFORT PLUS SOFT TIP CANNULAS - PEDIATRIC WITH KINK RESISTANT TUBING
- COMFORT PLUS SOFT TIP CANNULAS - PREMATURE WITH KINK RESISTANT TUBING
- COMFORT SOFT PLUS ADULT CANNULA
- COMFORT SOFT PLUS CO2 SAMPLING NASAL CANNULA
- COMFORT SOFT PLUS FLOEASY HIGH FLOW CANNOLA
- COMFORT SOFT PLUS INFANT NASAL CANNULA, HIGH FLOW
- COMFORT SOFT PLUS INFANT SOFT-TIPPED NASAL CANNULA W/KROT
- COMFORT SOFT PLUS NEONATAL CANNULA HIGH FLOW
- COMFORT SOFT PLUS PEDIATRIC NASAL CANNULA HIGH FLOW
- COMFORT SOFT PLUS PEDIATRIC O2/CO2 SAMPLING NASAL CANNULA
- COMFORT SOFT PLUS PREMATURE NASAL CANNULA HIGH FLOW
- CONVENTIONAL CANNULA SETS - ADULT HARNESS WITH CONNECTOR
- CONVENTIONAL CANNULA SETS - ADULT WITH KINK RESISTANT TUBING
- CONVENTIONAL CANNULA SETS WITH OXYGEN TUBING CONNECTOR
- CONVENTIONAL O2 MASKS, MEDIUM CONCENTRATION OXYGEN MASK WITH SUPPLY TUBING
- NON-REBREATHER MASK, ADULT WITH KINK RESISTANT TUBING
- NON-REBREATHER MASK, PEDIATRIC WITH KINK RESISTANT TUBING
- PRESSURE SAFE, COMFORT SOFT PLUS, INFANT NASAL
- PRESSURE SAFE, COMFORT SOFT PLUS, INFANT NASAL CANNULA, HIGH FLOW, WITH MANOMETER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.