TAUROPACE™ ANTIMICROBIAL SOLUTION FOR THE PREVENTION OF CIED INFECTIONS

0344

ANTIMICROBIAL SOLUTION FOR THE PREVENTION OF CIED INFECTIONS

0344

Indication: This device is intended to be used as disinfecting solution for implantation of cardiac implantable electronic devices (CIED) including its components, (e.g. leads) in any adult patient.

Description: TauroPace™ is a device preventing contamination of the CIED and its components for the process of implantation reducing the risk of microbial infectious contamination of the implantation pocket.

Application: TauroPace™ is used for the implantation process of cardiac implantable devices. Every component of the CIED has to be covered with TauroPace™.

Details see instruction for use.

Effectiveness: Due to its micro-biocidal activity microbial contamination on the surface of cardiac implantable electronic devices (CIEDs) is eradicated and a hostile environment is created. TauroPace™ contains taurolidine as active ingredient.

Safety: No safety issues are to be expected from unintended exposure of the implantation pocket (e.g. rinsing). Nevertheless, TauroPace™ coming into contact with the implantation pocket needs to be removed before suture.

Storage and shipment: Do not store TauroPace™ in a refrigerator. It must be stored and shipped at a temperature between 15°C to 25°C. Packaging configuration: The following packaging configurations are available for TauroPace™: 10 x 100 mL vials; 10 x 250 mL vials.

Manufacturer:

TauroPharm GmbH August-Bebel-Str. 51 D-97297 Waldbüttelbrunn Tel.: +49 (0) 931 304 299-0

ISO 13485

This information does not replace the instruction for use.

85108/47/19

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