Blood collection tubing set

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)

01-11-2019

Dostopno od:
Fresenius Medical Care Packs Australia
Razred:
Class Is
Status dovoljenje:
Included
Številka dovoljenja:
323684

Public Summary

Summary for ARTG Entry:

323684

Fresenius Medical Care Packs Australia - Blood collection tubing set

ARTG entry for

Medical Device Included Class Is

Sponsor

Fresenius Medical Care Packs Australia

Postal Address

786 Stud Road,SCORESBY, VIC, 3179

Australia

ARTG Start Date

17/09/2019

Product category

Medical Device Class Is

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

Fresenius Medical Care Packs Australia

786 Stud Road

SCORESBY, VIC, 3179

Australia

Products

1. Blood collection tubing set

Product Type

Procedure Pack

Effective date

17/09/2019

GMDN

44903 Blood collection tubing set

Intended purpose

A collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used

to transfer blood or blood components (e.g., peripheral stem cells) into containers or between containers

for processing or storage. This is a single-use device.

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 04:14:23 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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