SAM IO? Intraosseous Access System - Driver and Accessories - Intraosseous-access handpiece, infusion, manual
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
28-05-2020
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Available from:
Ferno Australia Pty Ltd
Class:
Class I
Manufactured by:
SAM Medical Products 12200 SW Tualatin Road Suite 200, Tualatin, OR, 97062 United States Of America
Therapeutic area:
64650 - Intraosseous-access handpiece, infusion, manual
Therapeutic indications:
A hand-held, manually-powered device designed to be used with a separate rotary cutting needle (endpiece) to access bone marrow for intraosseous (IO) infusion of fluids and medication. It is used as an alternative to intravenous (IV) access typically when IV access is not feasible. The SAM IO? Driver is a reusable device. The SAM IO? Adaptor, which attaches to the SAM IO? Driver to accommodate alternative IO needle designs, is a single-use device.
Authorization status:
A
Authorization date:
2020-05-22
