XVIVO Disposable Lung Kit 19046

GUDID 07350069520401

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

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 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 ID: 07350069520401
• NIH Device Record Key: 1b91da75-7a9d-499a-8ec9-039308a69650
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XVIVO Disposable Lung Kit
• Version Model Number: 19046
• Catalog Number: 19046
• Company DUNS: 559895730
• Company Name: Xvivo Perfusion AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350069520401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P180014

FDA Product Code

• PHO: Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-09
• Device Publish Date: 2023-09-29

Devices Manufactured by Xvivo Perfusion AB

• 07350069520401 - XVIVO Disposable Lung Kit: 2023-10-09The 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.
• 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