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Pressure Injectable PICC pre-loaded with Arrow NaviCurve Stylet - Catheter, central venous, peripherally inserted - ARTG 474789

Access comprehensive regulatory information for Pressure Injectable PICC pre-loaded with Arrow NaviCurve Stylet - Catheter, central venous, peripherally inserted in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 474789 and sponsored by Teleflex Medical Australia Pty Ltd, manufactured by Arrow International LLC Subsidiary of Teleflex Incorporated in United States of America. The device registration started on December 24, 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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TGA ARTG Official Data
Class III
ARTG 474789
Class III
Pressure Injectable PICC pre-loaded with Arrow NaviCurve Stylet - Catheter, central venous, peripherally inserted
ARTG ID: 474789
Good Name: Teleflex Medical Australia Pty Ltd - Pressure Injectable PICC pre-loaded with Arrow NaviCurve Stylet - Catheter, central venous, peripherally inserted
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Intended Purpose

This kit contains a collection of sterile devices and materials intended to provide long-term (>30 days) venous access to the central circulation. The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the PI PICC may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate ranges from 4 mL/sec to 6 mL/sec. The Arrow Navicurve Stylet is intended for use with VPS Rhythm systems to provide PICC navigation using electromagnetic technology (VPS Rhythm DLX device supplied separately).

Device Classification
Risk Class
Class III
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
474789
Start Date
December 24, 2024
Effective Date
December 24, 2024
Manufacturer
Country
United States of America
Address
3015 Carrington Mill Blvd, Morrisville, North Carolina, 27560