MEDISAFE WITH - Ambulatory insulin infusion pump, electronic, non-software-dosing
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
18-10-2022
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Available from:
Terumo Australia Pty Ltd
Class:
Class IIb
Manufactured by:
Terumo Corporation 44-1 2-Chome Hatagaya, Shibuya-Ku, Tokyo, 151 0072 Japan
Therapeutic area:
64889 - Ambulatory insulin infusion pump, electronic, non-software-dosing
Therapeutic indications:
MEDISAFE WITH is an insulin pump system exclusive for continuous subcutaneous insulin infusion to manage diabetes mellitus. The complete system consists of the main pump unit, cartridge, remote control, filling device, and infusion set with protective cover. The MEDISAFE WITH Main Pump Unit and MEDISAFE WITH Remote Control are reusable devices
Authorization status:
A
Authorization date:
2022-09-09
