Sphygmomanometer

Main information

  • Trade name:
  • Sphygmomanometer, electronic, automatic
  • Class:
  • (Export Only) Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Sphygmomanometer, electronic, automatic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221270
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221270

Uscom Ltd - Sphygmomanometer, electronic, automatic

ARTG entry for

Medical Device Included (Export Only) Class 1

Sponsor

Uscom Ltd

Postal Address

Level 8 66 Clarence Street,Sydney, NSW, 2000

Australia

ARTG Start Date

14/03/2014

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

Uscom Ltd

Level 7 / 10 Loftus Street

SYDNEY, NSW, 2000

Australia

Products

1. Sphygmomanometer, electronic, automatic

Product Type

Single Device Product

Effective date

14/03/2014

GMDN

16173 Automatic-inflation electronic sphygmomanometer, non-portable

Intended purpose

BP+ is a non-invasive, compact standalone measurement device that automatically measures systolic and

diastolic pressure, and pulse rate in adult and paediatric patients. BP+ also provides non-invasive central

(aortic) systolic and diastolic blood pressure, augmentation index, pulse waveform and other parameters

intended for use in adult patients.

BP+ performs measurements using a conventional oscillometric method via a brachial cuff on the upper

arm.

The device is intended to be used under supervision by qualified healthcare personnel. The device is not

intended for operating theatre, intensive care, or continuous patient monitoring use.

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 01:33:42 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.

Visit www.tga.gov.au for contact information