Corometrics

Fluid and Blood Warming System

ARTG Certificate enFlow System Jan 2015

Certificate

2 Pages

Australian Register of Therapeutic Goods Certificate Issued to  CareFusion Australia 316 Pty Ltd for approval to supply  CareFusion Australia 316 Pty Ltd - Conduction blood/fluid warmer ARTG Identifier  232830  ARTG Start date  16/01/2015  Product Category  Medical Device Included Class IIb  GMDN  47616  GMDN Term  Conduction blood/fluid warmer  Intended Purpose  A mains electricity device designed for in-line heating of banked blood, blood products, intravenous (IV) solutions, and irrigation fluids, typically from about 4ºC to near body temperature (i.e., 35 to 37ºC) before infusion, through the conduction of heat. The device usually includes a surface heat exchanger (e.g., heated dry plate) for the conduction of heat to the infusion blood/fluid via a disposable set (e.g., tubing or pouch); it also includes temperature controls and/or alarms. The warmer is used to minimize adverse thermal reactions in the patient. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid.  Manufacturer Details  Address  Certificate number(s)  Vital Signs Inc  20 Campus Road TOTOWA, NJ, 07512 United States Of America  DV-2014-MC-17901-1  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 Product Review, 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 and adverse events received by the manufacturer relating to problems with the use of the device that have been received by them over the year. For orthopaedic implant prosthesis that have been re-classified from Class IIb to Class III medical devices, annual report information must be submitted if the device meets either of the following criteria: I.The device was subject to a TGA application audit based on revision rate when the
File Type: PDF
File Size: 150 KB
File Name: artg_certificate_enflow_system_jan_2015.pdf

By clicking Download you are confirming this is the correct document for your purposes
and that you agree to our Terms & Conditions