Heating

Main information

  • Trade name:
  • Heating pad, chemically-reactive gel
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Heating pad, chemically-reactive gel
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218101
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218101

In Vitro Technologies Pty Ltd - Heating pad, chemically-reactive gel

ARTG entry for

Medical Device Included Class IIa

Sponsor

In Vitro Technologies Pty Ltd

Postal Address

7-9 Summit Road,NOBLE PARK, VIC, 3174

Australia

ARTG Start Date

5/12/2013

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

Cooper Surgical Inc

95 Corporate Drive

Trumbull, CT, 06611

United States Of America

Products

1. Heating pad, chemically-reactive gel

Product Type

Single Device Product

Effective date

5/12/2013

GMDN

46248 Heating pad, chemically-reactive gel

Intended purpose

An underlay that produces heat through chemical reaction to provide rapid thermal support during

transport of infants within a hospital or between hospitals. Designed with a soft outer casing, this gel-filled,

disposable thermal mattress is designed for use in all cases when cold stress is a concern. The

chemically-reactive gel is activated by the user to provide a heat of approximately normal body

temperature for a limited period. The gel heats quickly to minimise the risk of hypothermia. This is a

single-use device.

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 11:50:47 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

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