Adaptor

Main information

  • Trade name:
  • Adaptor, blood collecting tube, single use
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Adaptor, blood collecting tube, single use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216810
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216810

Becton Dickinson Pty Ltd - Adaptor, blood collecting tube, single use

ARTG entry for

Medical Device Included Class 1

Sponsor

Becton Dickinson Pty Ltd

Postal Address

Locked Bag 3200,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

1/11/2013

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

Becton Dickinson and Company

Belliver Way Belliver Industrial Estate

Roborough Plymouth, Devon, PL6 7BP

Products

1. Adaptor, blood collecting tube, single use

Product Type

Single Device Product

Effective date

1/11/2013

GMDN

37566 Adaptor, blood collecting tube, single use

Intended purpose

The BD holder is intended to be coupled with a BD Vacutainer® PrecisionGlide™ Blood Collection Needle

in order to

facilitate the insertion of the needle into the patient's vein and to help guide the evacuated blood collection

tube onto

the non-patient (NP) end of the needle during the blood collection process.

The intended users of this device are trained phlebotomists or other suitably trained healthcare

professionals

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 04:12:17 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