Catheter-introduction

Main information

  • Trade name:
  • Catheter-introduction needle
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Catheter-introduction needle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216441
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216441

REM Systems Pty Ltd - Catheter-introduction needle

ARTG entry for

Medical Device Included Class IIa

Sponsor

REM Systems Pty Ltd

Postal Address

PO Box 766,NORTH RYDE, NSW, 1670

Australia

ARTG Start Date

23/10/2013

Product category

Medical Device Class IIa

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Argon Medical Devices Inc

1445 Flat Creek Road

Athens, Texas, 75751

United States Of America

Products

1. Catheter-introduction needle

Product Type

Single Device Product

Effective date

23/10/2013

GMDN

46802 Catheter-introduction needle

Intended purpose

To facilitate the placement of devices such as guidewires, indwelling central venous catheters, peripherally

inserted central venous catheters, and diagnostic or monitoring probes into the vascular system.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 05:06:57 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

22-3-2019

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Pest categorisation of Cronartium spp. (non‐EU)

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