XVIVO Perfusion System (XPS™) 19030

GUDID 07350069520104

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

Lung donor-organ preservation/evaluation system Lung donor-organ preservation/evaluation system Lung donor-organ preservation/evaluation system Lung donor-organ preservation/evaluation system Lung donor-organ preservation/evaluation system Lung donor-organ preservation/evaluation system Lung donor-organ preservation/evaluation system Lung donor-organ preservation/evaluation system Lung donor-organ preservation/evaluation system Lung donor-organ preservation/evaluation system Lung donor-organ preservation/evaluation system Lung donor-organ preservation/evaluation system Lung donor-organ preservation/evaluation system Lung donor-organ preservation/evaluation system Lung donor-organ preservation/evaluation system Lung donor-organ preservation/evaluation system Lung donor-organ preservation/evaluation system
Primary Device ID07350069520104
NIH Device Record Keyd1d0ddbc-e0b5-46c3-8953-fcc925b39564
Commercial Distribution StatusIn Commercial Distribution
Brand NameXVIVO Perfusion System (XPS™)
Version Model Number19030
Catalog Number19030
Company DUNS559895730
Company NameXvivo Perfusion AB
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 303 395 9171
Emailinfo@xvivoperfusion.com
Phone+1 303 395 9171
Emailinfo@xvivoperfusion.com
Phone+1 303 395 9171
Emailinfo@xvivoperfusion.com
Phone+1 303 395 9171
Emailinfo@xvivoperfusion.com
Phone+1 303 395 9171
Emailinfo@xvivoperfusion.com
Phone+1 303 395 9171
Emailinfo@xvivoperfusion.com
Phone+1 303 395 9171
Emailinfo@xvivoperfusion.com
Phone+1 303 395 9171
Emailinfo@xvivoperfusion.com
Phone+1 303 395 9171
Emailinfo@xvivoperfusion.com
Phone+1 303 395 9171
Emailinfo@xvivoperfusion.com
Phone+1 303 395 9171
Emailinfo@xvivoperfusion.com
Phone+1 303 395 9171
Emailinfo@xvivoperfusion.com
Phone+1 303 395 9171
Emailinfo@xvivoperfusion.com
Phone+1 303 395 9171
Emailinfo@xvivoperfusion.com
Phone+1 303 395 9171
Emailinfo@xvivoperfusion.com
Phone+1 303 395 9171
Emailinfo@xvivoperfusion.com
Phone+1 303 395 9171
Emailinfo@xvivoperfusion.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107350069520104 [Primary]

FDA Product Code

PHONormothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-12-05
Device Publish Date2015-10-15

Devices Manufactured by Xvivo Perfusion AB

07350069520401 - XVIVO Disposable Lung Kit2023-10-09 The XVIVO Lung Disposables Kit contains a number of single-use, disposable sterile and non-sterile items intended to be used wit
07350069520425 - XVIVO Click Adapter2021-11-08 Intended as an adapter between the Perfadex® Plus bag and a tubing set with a standard spike.
07350069520500 - XVIVO Lung Cannula Set II™ 2021-10-11 XVIVO Lung Cannula Set II™ is a sterile, single-use set intended to be used to connect isolated donor lungs to an extracorpore
07350069520234 - PERFADEX Plus®2019-12-12 Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is intended for the flush
07350069520241 - PERFADEX Plus®2019-12-12 Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is intended for the flush
07350069520289 - PERFADEX Plus (Click US)2019-12-12 PERFADEX Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is indicated for the flushi
07350069520050 - Perfadex with THAM2019-12-05 Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal
07350069520067 - Perfadex with THAM2019-12-05 Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal
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