Dr. Marx Medizintechnik GmbH i.L.
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Bag Set Kidney Transplantat
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BAG SET - KIDNEY TRANSPLANT

The “BAG SET – KIDNEY TRANSPLANT” is used to ensure the sterile transport of kidneys (for right-hand and left-hand kidney in one set) removed from the donor and of the physiological solutions and coolants used during the extracorporeal time.

The bag set has been manufactured in keeping within the international standard DIN EN ISO 13 485, and is intended for single use. The bag set has been CE certified and meets the requirements of the German Medical Devices Act.

This bag set consists of three sterile bag sets fitted into each other, one for each kidney, of about 25 cm (10 in.) in width and 40 cm (16 in.) in height. Three of these bags each are marked with a large red letter L for the left kidney and with a large green letter R for the right kidney. Each of the six large bags 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.

Five other sterile bags (10 cm (4 in.) in width and 20 cm (8 in.) in length) are enclosed for the sterile transport of spleen specimen.

All these bags are made of a tested bio-compatible VA-Polyolefin and are manufactured specifically for the transport of the organ.

In order to ensure a sterile removal even under unfavourable conditions, the bags are welded 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 …/201x”.

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

The sterility starts on the inside of this peelable bag.