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Clinical data collection/management information application software - ARTG 470408

Access comprehensive regulatory information for Clinical data collection/management information application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 470408 and sponsored by Philips Electronics Australia Ltd, manufactured by Respironics Inc in United States of America. The device registration started on November 26, 2024.

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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Class IIa
ARTG 470408
Class IIa
Clinical data collection/management information application software
ARTG ID: 470408
Good Name: Philips Electronics Australia Ltd - Clinical data collection/management information application software
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Intended Purpose

Care Orchestrator Essence is intended for use by healthcare professionals (e.g., Physicians, Clinicians, Durable Medical Equipment providers) to gather, store, manage, and view compliance data for patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. The software also includes the ability to create new or updated prescriptions and/or performance settings, store them, and transmit them to compatible Respironics non-life supporting therapy devices and Respironics Trilogy and Trilogy Evo ventilator. Data and prescription settings are transferred between Care Orchestrator Essence and compatible devices via removable media. Care Orchestrator Essence is intended to be used in hospital, institutional, provider, and home care settings by healthcare representatives. The software does not perform automatic scoring or diagnosis. The data it provides are only one of several elements to consider when making decisions about patient therapy.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
470408
Start Date
November 26, 2024
Effective Date
November 26, 2024
Manufacturer
Country
United States of America
Address
1001 Murry Ridge Lane, Murrysville, PA, 15668-8550