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Device Description : STEEN Solution™ is intended for assessment of isolated lungs after removal from STEEN Solution™ is intended for assessment of isolated lungs after removal from the donor body for eventual transplantation into a recipient.
Device Class : 3
Duns Number: 559895730
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Silicone Tubing Set™ is intended for flushing of donor lungs in preparation The Silicone Tubing Set™ is intended for flushing of donor lungs in preparation for transplantation.
Device Class : 2
Duns Number: 559895730
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.Package size: 8x 1000 ml
Device Class : 2
Duns Number: 559895730
Premarket Exempt : No
Prescription Use : No
Device Description : Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.Package size 2 x 2800 ml
Device Class : 2
Duns Number: 559895730
Premarket Exempt : No
Prescription Use : No
Device Description : The XVIVO Organ Chamber™ is intended to be used as a temporary receptacle for is 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.
Device Class : 3
Duns Number: 559895730
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : XVIVO Lung Cannula Set™ is a sterile, single-use set intended to be used to conn 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.
Device Class : 3
Duns Number: 559895730
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The XVIVO Perfusion System (XPS™) is indicated for use in flushing and temporary 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.
Device Class : 3
Duns Number: 559895730
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The XVIVO PGM Disposable Sensors™ are a single-use, disposable in-line sensor in 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.
Device Class : 3
Duns Number: 559895730
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The XVIVO Lung Disposables Kit contains a number of single-use, disposable steri 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.
Device Class : 3
Duns Number: 559895730
Premarket Exempt : Yes
Prescription Use : No
Device Description : Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containin Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is intended for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.Package size: 10 x 1000ml
Device Class : 2
Duns Number: 559895730
Premarket Exempt : No
Prescription Use : Yes