Summary for ARTG Entry:
Medtronic Australasia Pty Ltd - Palindrome RT Repair Kit Reverse Tunneled Chronic Catheter Repair -
Catheter, haemodialysis, implantable
ARTG entry for
Medical Device Included Class III
Medtronic Australasia Pty Ltd
PO Box 945,NORTH RYDE BC, NSW, 1670
ARTG Start Date
Medical Device Class III
- 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.
15 Hampshire Street
Mansfield, MA, 02048
United States Of America
1. Palindrome RT Repair Kit Reverse Tunneled Chronic Catheter Repair - Catheter, haemodialysis,
Medical device system
37278 Catheter, haemodialysis, implantable
The components of the device facilitate the replacement of damaged hub/back end assembly(extension
tubing, luer adapter(s) or clamp(s)) or to repair the hub snap connector of a Palindrome RT
(reverse-tunneled) catheter. A repair can only be made if the tubing length between the hub snap
connector and the exit site is a minimum of 5.5 cm.
The sterile componnets included in the packaging are Hub/back end assembly, Hub snap connector,
Smooth jawed forceps, Sealing cap(s)Drape and Ruler
The device is an accesory intended for replacing the damaged back end assembly or hubsnap connector
components of Palindrome RT Chronic Catheters.
Length (cm) 19 cm to 55 cm
No Specific Conditions included on Record
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