Extracorporeal circuit waste bag, non-sterile

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

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PAR PAR (PAR)
08-11-2019

MAH:

Fresenius Medical Care Australia Pty Ltd

class:

Class I

manufactured_by:

Fresenius Medical Care AG & Co KGaA Else Kroner Strasse 1, Bad Homburg, Bad Homburg, D-61352 Germany

therapeutic_area:

58868 - Extracorporeal circuit waste bag, non-sterile

therapeutic_indication:

A non-sterile flexible container intended to be used for the collection of waste fluids during preparation and processing of an extracorporeal circuit (e.g., haemodialysis, haemofiltration, apheresis), including the collection and rinsing of ultrafiltrate fluid which may contain blood components. The device typically consists of a plastic pouch with a piece of short tubing and a connector (e.g., Luer-lock) intended to be connected to the tubing system of the extracorporeal circuit. The contents are considered potentially contaminated and should be disposed of according to local requirements. This is a single-use device.

authorization_status:

A

authorization_date:

2019-09-18