Summary for ARTG Entry:
KCI Medical Australia Pty Ltd - Suction unit, electric powered
ARTG entry for
Medical Device Included Class IIa
KCI Medical Australia Pty Ltd
PO Box 1541,LANE COVE, NSW, 1595
ARTG Start Date
Medical Device Class IIa
- 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.
KCI USA Inc
12930 IH 10 West
San Antonio, TX, 78249
United States Of America
1. Suction unit, electric powered
Single Device Product
36777 Suction unit, electric powered
The ABThera™ Open Abdomen Negative Pressure Therapy System is indicated for temporary bridging of
abdominal wall openings where primary closure is not possible and or repeat abdominal entries are
necessary. The Intended Use of this dressing is for use in open abdominal wounds, with exposed viscera,
including but not limited to abdominal compartment syndrome. The intended care setting is a closely
monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be
applied in the operating theater.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 07:03:12 AEDT
This is not an ARTG Certificate document.
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