Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
AA-Med Pty Ltd - Blood loss estimation canister insert/label
ARTG entry for
Medical Device Included Class IIa
AA-Med Pty Ltd
Level 8 / 1 Chandos Street,St Leonards, NSW, 2065
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.
Gauss Surgical Inc
334 State Street Suite 201
LOS ALTOS, CA, 94022
United States Of America
1. Blood loss estimation canister insert/label
Single Device Product
61697 Blood loss estimation canister insert/label
The Triton Canister System is a software application intended to be used as adjunct in the estimation of
blood loss. It is intended to be used blood bearing canisters, software, hardware, and accessory items
which have been validated for use with the system to estimate the hemoglobin (Hb) mass contained within
canisters with the input of the total volume in each canister. The Triton Canister System is also intended to
calculate an estimate of blood volume in blood bearing canisters from the estimated Hb mass and a
user-entered patient serum Hb value. The validated canister types, hardware, software, accessory
devices, Hb concentrations, and Hb mass ranges are listed in the Instructions for Use.
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Produced at 02.11.2019 at 04:45:12 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.
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