Medical device licence · 86364 · Class 2
DISPOSABLE HYPERINFLATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 16, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 86364
- Licence holder
- Ambu ABallerupdk, Denmark
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- June 16, 2011
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMBU DISPOSABLE HYPERINFLATION SYSTEM, 1/2L BAG, 7' O2 AND MANOMETER, 40 CM H2O POP-OFF VALVE WITH OVERRIDE
- AMBU DISPOSABLE HYPERINFLATION SYSTEM, 1L BAG, 7' O2 AND MANOMETER, 40 CM H2O POP-OFF VALVE WITH OVERRIDE
- AMBU DISPOSABLE HYPERINFLATION SYSTEM, 1L BAG, 7' O2 AND MANOMETER, PEDIATRIC MASK, 40 CM H2O POP-OFF VALVE WITH OVERRIDE
- DISPOSABLE HYPERINFLATION SYSTEM, HYPERINFLATION ELBOW, MANOMETER DOCK, 7' O2 AND MANOMETER
- DISPOSABLE HYPERINFLATION SYSTEM, HYPERINFLATION SET (LATEX FREE) 7' O2 AND MANOMETER
- DISPOSABLE HYPERINFLATION SYSTEM, HYPERINFLATION SET (LATEX FREE) 7' O2 AND MANOMETER, SERIES 900 INFANT MASK
- DISPOSABLE HYPERINFLATION SYSTEM, HYPERINFLATION SET (LATEX FREE) 7' O2 AND MANOMETER, SERIES 900 NEONATAL MASK
- DISPOSABLE HYPERINFLATION SYSTEM, HYPERINFLATION SET (LATEX FREE) 7' O2 AND PRESSURE LINES
- DISPOSABLE HYPERINFLATION SYSTEM, HYPERINFLATION SET (LATEX FREE) 7' O2 AND PRESSURE LINES, SERIES 900 INFANT MASK
- DISPOSABLE HYPERINFLATION SYSTEM, HYPERINFLATION SET (LATEX FREE) 7' O2 AND PRESSURE LINES, SERIES 900 NEONATAL MASK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.