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Intravenous catheter holder - ARTG 471088

Access comprehensive regulatory information for Intravenous catheter holder in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 471088 and sponsored by Medical Specialties Australasia Pty Ltd, manufactured by HB Fuller Medical Adhesives Technologies LLC in United States of America. The device registration started on November 29, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class IIa
ARTG 471088
Class IIa
Intravenous catheter holder
ARTG ID: 471088
Good Name: Medical Specialties Australasia Pty Ltd - Intravenous catheter holder
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Intended Purpose

Catheter securement adhesive to be applied as a film forming securement and sealant at the point of vascular access (catheter skin entry). The film holds the catheter to the skin to reduce catheter movement, migration, and/or dislodgment. It is used to protect the catheter skin entry site by creating a sealant that immobilizes surface bacteria, preventing them from entering into the catheter skin entry site while also providing a moisture barrier. The device is supplied sterile and is intended for single-use. It is intended to be used with a transparent film dressing [supplied separately] for the securement of short-term and long-term vascular access catheters including peripheral IVs, PICCs and CVCs.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
471088
Start Date
November 29, 2024
Effective Date
November 29, 2024
Manufacturer
Country
United States of America
Address
506 Pine Mountain Rd, Hudsdon, North Carolina, 28638