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Product Classification / EMDN Category

FDA Product Code: PHO

Directory of devices assigned to product classification code PHO.

classification Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs Manufacturer:
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gudid The XVIVO Lung Disposables Kit contains a number of single-use, disposable sterile and non-sterile items intended to be used with the XVIVO Perfusion System (XPS) for ex vivo reconditioning of donor lungs. Manufacturer: Xvivo Perfusion AB
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gudid XVIVO Lung Cannula Set II is a sterile, single-use set intended to be used to connect isolated donor lungs to an extracorporeal perfusion system for ex-vivo assessment. Manufacturer: Xvivo Perfusion AB
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gudid The XVIVO Lung Disposables Kit contains a number of single-use, disposable sterile and non-sterile items intended to be used with the XVIVO Perfusion System (XPS) for ex vivo reconditioning of donor lungs. Manufacturer: Xvivo Perfusion AB
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gudid The XVIVO PGM Disposable Sensors are a single-use, disposable in-line sensor intended to be used with the XVIVO Perfusion System (XPS) to monitor the pH and dissolved pO2 gas in STEEN Solution during ex-vivo lung assessment. Manufacturer: Xvivo Perfusion AB
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gudid The XVIVO Perfusion System (XPS) is indicated for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex-vivo function of the lungs can be reas-sessed for transplantation. Manufacturer: Xvivo Perfusion AB
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gudid XVIVO Lung Cannula Set is a sterile, single-use set intended to be used to connect isolated donor lungs to an extracorporeal perfusion system for ex-vivo assessment. Manufacturer: Xvivo Perfusion AB
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gudid The XVIVO Organ Chamber is intended to be used as a temporary receptacle for isolated donor lungs in preparation for eventual transplantation into a recipient. Manufacturer: Xvivo Perfusion AB
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gudid STEEN Solution is intended for assessment of isolated lungs after removal from the donor body for eventual transplantation into a recipient. Manufacturer: Xvivo Perfusion AB
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pma Normothermic preservation system for transplantation of initially unacceptable donor lungs Manufacturer: Xvivo Perfusion, Inc.
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pma Normothermic preservation system for transplantation of initially unacceptable donor lungs Manufacturer: Xvivo Perfusion, Inc.
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pma Normothermic preservation system for transplantation of initially unacceptable donor lungs Manufacturer: Lung Bioengineering, Inc.
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pma Normothermic preservation system for transplantation of initially unacceptable donor lungs Manufacturer: Xvivo Perfusion, Inc.
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pma Normothermic preservation system for transplantation of initially unacceptable donor lungs Manufacturer: Traferox Technologies, Inc.
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pma Normothermic preservation system for transplantation of initially unacceptable donor lungs Manufacturer: Xvivo Perfusion, Inc.
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