Tourniquet

Main information

  • Trade name:
  • Tourniquet, pneumatic
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Tourniquet, pneumatic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217960
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217960

Medsell Sales Pty Ltd T/A Denyers International - Tourniquet, pneumatic

ARTG entry for

Medical Device Included Class IIa

Sponsor

Denyers Pty Ltd T/a Denyers International

Postal Address

44-46 Nelson Street,MOORABBIN, VIC, 3189

Australia

ARTG Start Date

2/12/2013

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

Hammarplast Medical AB

Box 2069 Kartasgatan 8

Lidkoping, , 531 02

Sweden

Products

1. Tourniquet, pneumatic

Product Type

Single Device Product

Effective date

2/12/2013

GMDN

14074 Tourniquet, pneumatic

Intended purpose

The device is intended to be used as an electronic tourniquet instrument to control venous and

arterial blood circulation to an extremity for a period of time, as for operations in a bloodless

field. The pressure is applied circumferentially upon the skin and underlying tissues of an

extremity via a cuff; this pressure is transferred to the walls of vessels, causing them to become

temporarily

occluded. It is generally used as a tool for a medical professional in applications such as

cannulation or to stem the flow of traumatic bleeding.

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 02.12.2017 at 04:50:12 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

25-5-2018

Urgent Medical Device Recall: Sam XT Extremity Tourniquet

Urgent Medical Device Recall: Sam XT Extremity Tourniquet

SAM Medical today announced it is conducting a voluntary international recall of all unused SAM XT Extremity Tourniquets (SAM XT). The company initiated the recall after internal testing indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. To date, there have been no reports of adverse health consequences received. This recall is being made with the knowledge of the Food and Drug A...

FDA - U.S. Food and Drug Administration

There are no news related to this product.