Dr. Marx Medizintechnik GmbH i.L.
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Heart Transplant
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BAG SET - HEART TRANSPLANT

The “BAG SET – HEART TRANSPLANT” is used to ensure the sterile transport of the heart removed from the donor during the extracorporeal time. The bag set has been manufactured in keeping with international standard DIN EN ISO 13 485. The bag set has been CE certified and meets the requirements of the German Medical Devices Act. It is intended for single use. This bag set provides a method of protecting the removed heart in three bags fitted into each other.

The “BAG SET – HEART TRANSPLANT” consists of three thin-walled but high-strength bags. In application, the two inside bags are about 25 cm (10 in.) in width and 40 cm (16 in.) in length, and are made of a tested bio-compatible VA-Polyolefin. In this type, the external bag is about 40 x 55 cm (16 x 22 in.) in size, and is made of a soft bio-compatible VA-Polyolefin. Both types of bag have been produced specifically for the transport of organs. Each bag has been provided with thin but firm and well knottable threads so that the bags can be pressed in deeply enough (thus closing up tightly) when knotting the threads.

In order to ensure a sterile removal even under unfavourable conditions, the bags are welded twice in two sterile barriers, one inside the other. On account of the additional protection by an internal covering of the sterile product (in keeping with the German standard DIN 58953, parts 1, 2.43), a triple packaging of the sterile product is provided.

The sterilisation has taken place at the point in time mentioned on the label (rendering month and year) by means of gamma rays, 25 kGy = 2.5 Megarad +/-10 %.

The shelf life is at least five years, and is marked on the label as “to be used by calendar week …/201x”.

This long shelf life is achieved by a peelable external envelope made of leak-proof, welded, pore-free Polyolefin-Polyamid films and by a dustproof external bag (which encloses five BAG SETS – HEART TRANSPLANT each).

The sterility starts on the inside of this peelable bag.

STERILE BAG SETS for the storage of human tissue (donor organs, limbs amputated in accidents and cultered skin) are our forte. Please enquire for other applications because we are sure to have a suitable system for your special demands as well.