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Basic endotracheal tube, single-use - ARTG 427793

Access comprehensive regulatory information for Basic endotracheal tube, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 427793 and sponsored by AMBU Australia Pty Ltd, manufactured by Ambu AS in Denmark. The device registration started on November 13, 2023.

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.

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TGA ARTG Official Data
Class IIb
ARTG 427793
Class IIb
Basic endotracheal tube, single-use
ARTG ID: 427793
Good Name: AMBU Australia Pty Ltd - Basic endotracheal tube, single-use
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Intended Purpose

VivaSight 2 SLT + EBB Kit is a sterile, single-use endotracheal tube and Endobronchial Blocker intended for oral intubation procedures where isolation of one lung from the other, e.g. for thoracic surgery. is required. It is intended to be used as a temporary artificial airway in adults requiring mechanical ventilation. Intubation with VivaSight 2 SLT + EBB Kit is indicated for patients with difficult airway anatomy, pathological lung conditions or other medical conditions that require endotracheal intubation and mechanical ventilation in conjunction with an endobronchial blocker.

Device Classification
Risk Class
Class IIb
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
427793
Start Date
November 13, 2023
Effective Date
November 13, 2023
Manufacturer
Country
Denmark
Address
Baltorpbakken 13, Ballerup, DK-2750