Main information

  • Trade name:
  • Cold pack, reusable
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Cold pack, reusable
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221366
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Device Consulting Pty Ltd - Cold pack, reusable

ARTG entry for

Medical Device Included Class 1


Device Consulting Pty Ltd

Postal Address

Unit 16 / 24 Brand Drive,THOMASTOWN, VIC, 3074


ARTG Start Date


Product category

Medical Device Class 1



Approval area

Medical Devices


- 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.




Miramar Labs Inc

2790 Walsh Avenue

Santa Clara, CA, 95051

United States Of America


1. Cold pack, reusable

Product Type

Single Device Product

Effective date



42823 Cold pack, reusable

Intended purpose

Accessory items to the miraDry system used for the treatment of primary axillary hyperhidrosis. Used to

cool the underarm area and reduce swelling.

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

Public Summary

Page 1 of

Produced at 10.11.2017 at 01:19:42 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.

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