xvivoperfusion.comKIDNEY ASSIST-transport
XVIVO Perfusion AB
XVIVO PERFUSION AB
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007710603 | 3007710603 | XVIVO PERFUSION AB | 1 | N | 2026-01-01 | Entreprenorsstraket 10 Molndal Vastra Gotaland SE 43153 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07350069520036 | STEEN Solution™ - STEEN Solution™ is intended for assessment of isolated lungs after removal from the donor body for eventual transplantation into a recipient. | +1 303 395 9171 | info@xvivoperfusion.com |
| 07350069520050 | 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 | +13033959171 | info@xvivoperfusion.com |
| 07350069520234 | 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 | +13033959171 | info@xvivoperfusion.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 105716 | 1184693402 | P180014 | XPS™ with Steen Solution™ Perfusate | PHO | 2019-04-26 |
| 105716 | 1183596256 | K170826 | Perfadex Plus | KDN | 2018-06-22 |
| 105716 | 1120666479 |
Product Codes Associated With Registrations#
PMN#
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.
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.
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: 10 x 1000ml
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: 2 x 3000ml
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: 2 x 3000ml
2018-09-19
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
2019-12-04
STEEN Solution™ - STEEN Solution™ is intended for assessment of isolated lungs after removal from the donor body for eventual transplantation into a recipient.
2015-10-15
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
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 2 x 2800 ml
2016-06-13
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.
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.
2021-10-01
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.
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.
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.
2015-10-15
XVIVO Click Adapter - Intended as an adapter between the Perfadex® Plus bag and a tubing set with a standard spike.
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.
2015-10-15
Silicon Tubing Set - The Silicone Tubing Set™ is intended for flushing of donor lungs in preparation for transplantation.
2016-11-11
XVIVO Click Adapter - Intended as an adapter between the Perfadex® Plus bag and a tubing set with a standard spike.
2018-09-19