Medical device licence · 532 · Class 4
PRESOURCE CARDIOVASCULAR PACKS
Yes: licensed in Canada
Licence status Issued (active); first licensed December 17, 1998. It is in Health Canada’s list of active licences.
- Licence number
- 532
- Licence holder
- Cardinal Health 200, LLCLeawood, Kansas, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Device Group Family
- First licensed
- December 17, 1998
- Devices covered
- 19
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANGIOGRAPHY PACK
- AORTA/ANEURYSM PACK
- ARTERIAL LINE PACK
- BYPASS (PONTAGE) PACKS
- CARDIAC CATHETERIZATION PACK
- CARDIAC IMPLANT PACK
- CORONARY ARTERY BYPASS GRAFTING (CABG) PACKS
- CORONARY PACK
- ENDARTERECTOMY PACKS
- ENDOVASCULAR ANEURYSM REPAIR (EVAR) PACKS
- FEMORAL POPLITEAL (FEM POP) PACKS
- GENERAL CARDIOVASCULAR PACK
- HEART PACK
- LUNG PACKS (ENSEMBLE POUMONS)
- PACEMAKER PACKS
- PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE KITS
- THORACIC PACK
- VASCULAR PACK
- VENOUS DAY SURGERY PACKS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.