Warmer

Main information

  • Trade name:
  • Warmer, instrument
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Warmer, instrument
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219605
  • Last update:
  • 09-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219605

De Fries Industries Pty Ltd - Warmer, instrument

ARTG entry for

Medical Device Included Class Is

Sponsor

Defries Industries Pty Ltd

Postal Address

PO Box 876,NOBLE PARK, VIC, 3174

Australia

ARTG Start Date

24/01/2014

Product category

Medical Device Class Is

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

DeRoyal Industries Inc

200 DeBusk Lane

Powell, TN, 37849

United States Of America

Products

1. Warmer, instrument

Product Type

Single Device Product

Effective date

24/01/2014

GMDN

36816 Warmer, instrument

Intended purpose

To pre-warm cold instruments, e.g. endoscopes, that are to be introduced into the body orifices or

particular parts of the body.

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 07:03:42 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

15-5-2018

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