Blood loss estimation canister insert/label

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
AA-Med Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
322871

Public Summary

Summary for ARTG Entry:

322871

AA-Med Pty Ltd - Blood loss estimation canister insert/label

ARTG entry for

Medical Device Included Class IIa

Sponsor

AA-Med Pty Ltd

Postal Address

Level 8 / 1 Chandos Street,St Leonards, NSW, 2065

Australia

ARTG Start Date

9/09/2019

Product category

Medical Device Class IIa

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

Gauss Surgical Inc

334 State Street Suite 201

LOS ALTOS, CA, 94022

United States Of America

Products

1. Blood loss estimation canister insert/label

Product Type

Single Device Product

Effective date

9/09/2019

GMDN

61697 Blood loss estimation canister insert/label

Intended purpose

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.

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 04:45:12 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.

Visit www.tga.gov.au for contact information

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