Tourniquet, pneumatic

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

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Available from:
AA-Med Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
324063

Public Summary

Summary for ARTG Entry:

324063

AA-Med Pty Ltd - Tourniquet, pneumatic

ARTG entry for

Medical Device Included Class IIa

Sponsor

AA-Med Pty Ltd

Postal Address

Level 8 / 1 Chandos Street,St Leonards, NSW, 2065

Australia

ARTG Start Date

26/09/2019

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

Delfi Medical Innovations Inc

106 - 1099 West 8th Ave

, Vancouver, BC V6H 1C3

Canada

Products

1. Tourniquet, pneumatic

Product Type

Single Device Product

Effective date

26/09/2019

GMDN

14074 Tourniquet, pneumatic

Intended purpose

This device is intended to be used only with a Delfi BFR Tourniquet Cuff by a physician or physician's

designated licensed healthcare practitioner to preoperatively and/or postoperatively exert enough pressure

on the arterial blood flow in a patient's extremity to reduce or totally occlude blood flow into the limb.

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 03:45:06 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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