Medicine administration kit, percutaneous, medicated, single-use
Access comprehensive regulatory information for Medicine administration kit, percutaneous, medicated, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Sanofi-Aventis Australia Pty Ltd, manufactured by Sanofi Pasteur in France. The device registration started on January 18, 2018.
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Act-HIB (AUST R 130161) contains Haemophilus type b conjugate vaccine powder in vial, sodium chloride solution (diluent for reconstitution) in pre-filled syringe without attached needle and separate needles. There are 2 pack sizes; the single pack contains 1 vaccine vial, 1 diluent syringe and 2 needles and the 10 pack contains 10 vaccine vials, 10 diluent syringes and 20 needles. The needles are required for reconstitution and administration of reconstituted solution.