Australia TGA ARTG record

Suction system regulator, surgical

Australia TGA ARTG Registered Device · ICU Medical Australia Pty Ltd · ICU Medical Australia Pty Ltd · Class I · Started September 22, 2017

Good Name: ICU Medical Australia Pty Ltd - Suction system regulator, surgical

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General-Export

Registration information

Start Date: September 22, 2017
Effective Date: September 22, 2017

Sponsor

Name: ICU Medical Australia Pty Ltd

Manufacturer

Name: ICU Medical Australia Pty Ltd
Country: Australia
Address: Unit 4B 128-130 Frances Street, LIDCOMBE, NSW, 2141

Intended purpose

A device that is a component of a central vacuum-powered suction system and used to control the high degree of negative pressure (usually from 400 to 600 mm Hg) applied at the surgical site. The device usually includes a pressure regulation mechanism, pressure adjusting controls, and a calibrated manometer. It is typically connected to the wall outlet of a central vacuum system and used for the removal of secretions (e.g., vomitus, mucus, blood) during surgical procedures, as well as secretions in wound cavities after surgery.

About this record

Access comprehensive regulatory information for Suction system regulator, surgical in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by ICU Medical Australia Pty Ltd, manufactured by ICU Medical Australia Pty Ltd in Australia. The device registration started on September 22, 2017.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.