LMT nomag

Main information

  • Trade name:
  • LMT nomag IC 3.0 - Incubator, infant, transportable
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • LMT nomag IC 3.0 - Incubator, infant, transportable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216481
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216481

Imaging Solutions Pty Ltd - LMT nomag IC 3.0 - Incubator, infant, transportable

ARTG entry for

Medical Device Included Class IIb

Sponsor

Imaging Solutions Pty Ltd

Postal Address

PO Box 1768,SUNNYBANK HILLS, QLD, 4109

Australia

ARTG Start Date

23/10/2013

Product category

Medical Device Class IIb

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

LMT Lammers Medical Technology GmbH

Maria-Goeppert Strasse 5

, Lubeck, 23562

Germany

Products

1. LMT nomag IC 3.0 - Incubator, infant, transportable

Product Type

Medical device system

Effective date

23/10/2013

GMDN

35121 Incubator, infant, transportable

Intended purpose

nomag® IC is an infant incubator system for temporary use during MR imaging in clinical environments

and provided with a suitable trolley for intra hospital and transport. nomag® IC provides a controlled

environment of warmth and humidity for premature babies and sick infants. Optional integrated pulse

oximeter and accessories are for the continuous noninvasive monitoring of functional oxygen saturation of

arterial hemoglobin (SpO2) and Pulse Rate (measured by an SpO2 sensor)with pediatric and neonatal

patients.

Specific Conditions

No Specific Conditions included on Record

© 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 10.11.2017 at 05:02:28 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