XVIVO Organ Chamber™ 19020

GUDID 07350069520074

Lung donor-organ preservation/evaluation system chamber set

Primary Device ID	07350069520074
NIH Device Record Key	0fd695a2-d991-4b00-97c0-96c317c35631
Commercial Distribution Status	In Commercial Distribution
Brand Name	XVIVO Organ Chamber™
Version Model Number	19020
Catalog Number	19020
Company DUNS	559895730
Company Name	Xvivo Perfusion AB
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	07350069520074 [Primary]

PHO	Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

Steralize Prior To Use	false
Device Is Sterile	true

07350069520401 - XVIVO Disposable Lung Kit	2023-10-09 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 Adapter	2021-11-08 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 THAM	2019-12-05 Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal
07350069520067 - Perfadex with THAM	2019-12-05 Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal