XVIVO Organ Chamber™ 19020

GUDID 07350069520074

The XVIVO Organ Chamber™ is intended to be used as a temporary receptacle for isolated donor lungs in preparation for eventual transplantation into a

Xvivo Perfusion AB

Lung donor-organ preservation/evaluation system chamber set Lung donor-organ preservation/evaluation system chamber set Lung donor-organ preservation/evaluation system chamber set Lung donor-organ preservation/evaluation system chamber set Lung donor-organ preservation/evaluation system chamber set Lung donor-organ preservation/evaluation system chamber set Lung donor-organ preservation/evaluation system chamber set Lung donor-organ preservation/evaluation system chamber set Lung donor-organ preservation/evaluation system chamber set Lung donor-organ preservation/evaluation system chamber set Lung donor-organ preservation/evaluation system chamber set Lung donor-organ preservation/evaluation system chamber set Lung donor-organ preservation/evaluation system chamber set Lung donor-organ preservation/evaluation system chamber set Lung donor-organ preservation/evaluation system chamber set Lung donor-organ preservation/evaluation system chamber set Lung donor-organ preservation/evaluation system chamber set Lung donor-organ preservation/evaluation system lung-interface set Lung donor-organ preservation/evaluation system lung-interface set Lung donor-organ preservation/evaluation system lung-interface set Lung donor-organ preservation/evaluation system lung-interface set Lung donor-organ preservation/evaluation system lung-interface set Lung donor-organ preservation/evaluation system lung-interface set Lung donor-organ preservation/evaluation system lung-interface set Lung donor-organ preservation/evaluation system lung-interface set Lung donor-organ preservation/evaluation system lung-interface set Lung donor-organ preservation/evaluation system lung-interface set Lung donor-organ preservation/evaluation system lung-interface set Lung donor-organ preservation/evaluation system lung-interface set Lung donor-organ preservation/evaluation system lung-interface set Lung donor-organ preservation/evaluation system lung-interface set
Primary Device ID07350069520074
NIH Device Record Key0fd695a2-d991-4b00-97c0-96c317c35631
Commercial Distribution StatusIn Commercial Distribution
Brand NameXVIVO Organ Chamber™
Version Model Number19020
Catalog Number19020
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 Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107350069520074 [Primary]

FDA Product Code

PHONormothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
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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