Intravenous

Main information

  • Trade name:
  • Intravenous start kit
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Intravenous start kit
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219775
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219775

REM Systems Pty Ltd - Intravenous start kit

ARTG entry for

Medical Device Included Class IIa

Sponsor

REM Systems Pty Ltd

Postal Address

PO Box 766,NORTH RYDE, NSW, 1670

Australia

ARTG Start Date

31/01/2014

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

Tipromed Srl

Via E G Segre 6 Sorbolo a Levante

, di Brescello, 42041

Italy

Products

1. Intravenous start kit

Product Type

Single Device Product

Effective date

31/01/2014

GMDN

33963 Intravenous start kit

Intended purpose

Peripheral venous access for infusion or blood sampling.

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 06:36:53 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

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

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22-6-2018

Metronidazole intravenous infusion 500 mg/100 mL bag

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Shortage and althernative supply of Metronidazole intravenous infusion 500 mg/100 mL bag

Therapeutic Goods Administration - Australia

31-5-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities

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FDA’s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities

FDA - U.S. Food and Drug Administration

6-9-2012

Danish Pharmacovigilance Update, 16 August 2012

Danish Pharmacovigilance Update, 16 August 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Maximum single dose of intravenous ondansetron (Zofran® and others) now restricted to 16 mg.

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