Australian ARTG Registration Cerebral Somatic Oximeter System Number 141701 Class IIb July 2007

Australian Register of Therapeutic Goods Certificate Issued to

Covidien Pty Ltd for approval to supply

Covidien Pty Ltd - Cerebral/Somatic Oximeter System - Oximeter, cerebral ARTG Identifier

141701 Class IIb

ARTG Start date

5/07/2007

Product Category:

Medical Device Included Class IIb

GMDN

17942

GMDN Term

Oximeter, cerebral

Intended Purpose

A mains electricity (AC-powered) photoelectric device that noninvasively measures the brain tissue blood oxygen saturation and venous oxygen saturation in the brain. It is typically used as an adjunct monitor for the regional haemoglobin oxygen saturation of blood in the brain of a paediatric or adult patient.

Manufacturer Details

Address

Certificate number(s)

Somanetics Corporation

2600 Troy Center Drive Troy, MI, 48084 United States Of America

DV-2011-MC-03748-3

ARTG Standard Conditions The above Medical Device Included Class IIb has been entered on the Register subject to the following conditions: · The automatic conditions applicable to the inclusion of all kinds of medical devices in the Register are as specified in section 41FN of the Therapeutic Goods Act 1989. · The standard conditions that are imposed under section 41FO of the Therapeutic Goods Act 1989 when kinds of medical devices are included in the Register are as set out in the following paragraphs. · For a medical device included in the Register under Chapter 4 and imported into Australia, the Sponsor must ensure that information about the Sponsor is provided in such a way as to allow the sponsor to be identified. · Each sponsor shall retain records of the distribution of all of the sponsor's medical devices included in the Register under Chapter 4. In the case of records relating to a Class AIMD medical device, Class III medical device, or Class IIb medical device that is an implantable medical device, the distribution records shall be retained for a minimum period of 10 years. In the case of records relating to any other device, the distribution records shall be retained for a minimum period of 5 years. · The sponsor of a medical device included in the Register under Chapter 4 shall keep an up to date log of information of the kind specified in Regulation 5.8. · It is a condition of inclusion in the ARTG that the sponsor of a medical device that is an AIMD, Class III or implantable Class IIb provides three consecutive annual reports to the Head of the Office of Devices, Blood and Tissues, Therapeutic Goods Administration following inclusion of the device in the ARTG. (as specified in 5.8 of the regulations) Annual reports are due on 1 October each year. Reports should be for the period 1 July to 30 June. The first report following the date of inclusion in the ARTG must be for a period of at least six months but no longer than 18 months. Subsequent reports are to be provided on 1 October for a further 2 years. The annual report must include all complaints received by the manufacturer relating to problems with the use of the device that have been received by them over the year. · Where a medical device included in the Register, contains a substance which is included in the Fourth Schedule to the Customs (Prohibited Imports) Regulations or the Eighth Schedule to the Customs (Prohibited Exports) Regulations the Sponsor shall, at the time of importation or exportation of the medical device, be in possession of a licence and a permission for importation or exportation of each consignment of the goods as required by those regulations. · A sponsor shall ensure that a medical device within their control is stored and transported in