Australië - Engels - Department of Health (Therapeutic Goods Administration)
01-11-2019
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