Arterial

Main information

  • Trade name:
  • Arterial blood sampling kit
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Arterial blood sampling kit
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220908
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220908

Becton Dickinson Pty Ltd - Arterial blood sampling kit

ARTG entry for

Medical Device Included Class IIa

Sponsor

Becton Dickinson Pty Ltd

Postal Address

Locked Bag 3200,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

7/03/2014

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

Becton Dickinson and Company

Belliver Way Belliver Industrial Estate

Roborough Plymouth, Devon, PL6 7BP

Products

1. Arterial blood sampling kit

Product Type

Procedure Pack

Effective date

7/03/2014

GMDN

31336 Arterial blood sampling kit

Intended purpose

The BD CCCS (with needle) is a sterile, single use medical device. It is intended to be used to withdraw an

arterial

blood sample from the human body, and for the primary containment and preservation of a specimen for

analysis.

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 02:48:01 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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