XVIVO PERFUSION AB

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• xvivoperfusion.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMA#

• XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate

  2022-05-09

  XVIVO Perfusion, Inc.3666 S. Inca Streetenglewood, CO 80110 PMA NumberP180014 Supplement NumberS009 Date Received02/08/2022 Decision Date05/09/2022 Product Code PHO  Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Supplement Rea...

• XVIVO Perfusion System (XPS) with STEEN Solution Perfusate

  2022-05-09

  XVIVO Perfusion, Inc.3666 S. Inca Streetenglewood, CO 80110 PMA NumberP180014 Supplement NumberS008 Date Received02/08/2022 Decision Date05/09/2022 Product Code PHO  Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Supplement Rea...

• XVIVO Perfusion System (XPS)™ with STEEN Solution™ Perfusate

  2021-11-03

  XVIVO Perfusion, Inc.

• XVIVO Perfusion System with STEEN Solution Perfusate

  2020-10-23

  XVIVO Perfusion, Inc.

• XVIVO Perfusion System (XPS) with STEEN Solution Perfusate

  2020-04-26

  XVIVO Perfusion, Inc.

• Xvivo Perfusion System (XPS) with Steen Solution Perfusate

  2020-04-24

  XVIVO Perfusion, Inc.

• XVIVO Perfusion System (XPS) with STEEN Solution Perfusate

  2019-10-29

  XVIVO Perfusion, Inc.

• XPS™ with Steen Solution™ Perfusate

  2019-04-26

  XVIVO Perfusion, Inc.

PMN#

• KIDNEY ASSIST-transport

  2022-01-20

  XVIVO Perfusion AB

• Perfadex Plus

  2018-06-22

  XVIVO Perfusion AB

• PERFADEX AND PERFADEX WITH THAM

  2010-10-01

  XVIVO PERFUSION AB

GUDID#

• XVIVO Disposable Lung Kit - 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.

  Xvivo Perfusion AB

  2025-11-10

• XVIVO Disposable Lung Kit - 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.

  Xvivo Perfusion AB

  2023-09-29

• PERFADEX® Plus - 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: 2 x 3000ml

  Xvivo Perfusion AB

  2018-09-19

• PERFADEX Plus® - 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: 2 x 3000ml

  Xvivo Perfusion AB

  2019-12-04

• PERFADEX Plus® - 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

  Xvivo Perfusion AB

  2019-12-04

• Perfadex with THAM - 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

  Xvivo Perfusion AB

  2016-06-13

• Perfadex with THAM - 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

  Xvivo Perfusion AB

  2016-06-13

• STEEN Solution™ - STEEN Solution™ is intended for assessment of isolated lungs after removal from the donor body for eventual transplantation into a recipient.

  Xvivo Perfusion AB

  2015-10-15

• PERFADEX Plus (Click US) - PERFADEX Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is indicated 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

  Xvivo Perfusion AB

  2019-12-04

• XVIVO Lung Disposables Kit - 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.

  Xvivo Perfusion AB

  2015-10-15

• XVIVO PGM Disposable Sensors™ - 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.

  Xvivo Perfusion AB

  2015-10-15

• XVIVO Lung Cannula Set™ - 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.

  Xvivo Perfusion AB

  2015-10-15

• XVIVO Organ Chamber™ - 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.

  Xvivo Perfusion AB

  2015-10-15

• XVIVO Lung Cannula Set II™ - 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.

  Xvivo Perfusion AB

  2021-10-01

• XVIVO Click Adapter - Intended as an adapter between the Perfadex® Plus bag and a tubing set with a standard spike.

  Xvivo Perfusion AB

  2021-10-29

• XVIVO Perfusion System (XPS™) - 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.

  Xvivo Perfusion AB

  2015-10-15

• XVIVO Click Adapter - Intended as an adapter between the Perfadex® Plus bag and a tubing set with a standard spike.

  Xvivo Perfusion AB

  2018-09-19

• Silicon Tubing Set - The Silicone Tubing Set™ is intended for flushing of donor lungs in preparation for transplantation.

  Xvivo Perfusion AB

  2016-11-11