Compress, hot/cold pack, reusable

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Trenna Enterprises Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
321803

Public Summary

Summary for ARTG Entry:

321803

Trenna Enterprises Pty Ltd - Compress, hot/cold pack, reusable

ARTG entry for

Medical Device Included Class 1

Sponsor

Trenna Enterprises Pty Ltd

Postal Address

PO Box 301,Greensborough, VIC, 3088

Australia

ARTG Start Date

15/08/2019

Product category

Medical Device Class 1

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

Shanghai Bing Fan Industrial Co Ltd

No 18 Hang Fan Road 1 Building 2 Floor

Pu Dong New Area, Beijing,

China

Products

1. Compress, hot/cold pack, reusable

Product Type

Single Device Product

Effective date

15/08/2019

GMDN

37240 Compress, hot/cold pack, reusable

Intended purpose

Reusable gel breast packs designed to soothe tender and sore breasts and aid in breastfeeding. The

packs can be used warm or cold/frozen. Using warm helps assist with milk let down and using cold helps

to sooth sore and engorged breasts. The perineal pack can be used both warmed and cold to to help

decrease pain and swelling associated with birth trauma, haemorrhoids and vulval varicosities.

Specific Conditions

© 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 02.11.2019 at 06:55:11 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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