Medical device licence · 77651 · Class 2
INTEGO PET INFUSION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 23, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 77651
- Licence holder
- Bayer Medical Care Inc. Also Doing Business As Medrad, Inc.Indianola, PA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 23, 2008
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MEDRAD INTEGO PET INFUSION SYSTEM - MAIN
- MEDRAD INTEGO PET INFUSION SYSTEM - PATIENT ADMINISTRATION SET
- MEDRAD INTEGO PET INFUSION SYSTEM - SOURCE ADMINISTRATION SET
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “intego”. A notice may cover another product or only some lots: read it to see what it covers.
- Medrad Intego PET Infusion System - Source Administration SetsNovember 18, 2016 · Medical devices · Medical devices · Type I
- MEDRAD INTEGO PET INFUSION SYSTEM - SOURCE ADMINIOctober 5, 2016 · Medical devices · Type II
- MEDRAD INTEGO PET INFUSION SYSTEM - MAIN (2016-05-31)June 13, 2016 · Medical devices · Medical devices · Type II
- Medrad Intego Pet Infusion System - Source Admini (2015-11-30)February 1, 2016 · Medical devices · Health products · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.