AccessGUDID - DEVICE: XVIVO Lung Disposables Kit (07350069520142)

GUDID

Device Identifier (DI) Information

Brand Name: XVIVO Lung Disposables Kit
Version or Model: 19035
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 19035
Company Name: Xvivo Perfusion AB

Primary DI Number: 07350069520142
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 559895730 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Lung donor-organ preservation/evaluation system chamber set	A collection of sterile devices intended to be used with a lung donor-organ preservation/evaluation system. It typically consists of a lung chamber with tubing and a fluid reservoir, oxygenator, leukocyte filter, pressure sensors and a connection for a ventilator with a humidity filter that creates an ex-vivo environment for the preservation, reconditioning and evaluation of the organs. It typically includes surgical drapes to create a sterile field for surgery. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Lung donor-organ preservation/evaluation system chamber set

A collection of sterile devices intended to be used with a lung donor-organ preservation/evaluation system. It typically consists of a lung chamber with tubing and a fluid reservoir, oxygenator, leukocyte filter, pressure sensors and a connection for a ventilator with a humidity filter that creates an ex-vivo environment for the preservation, reconditioning and evaluation of the organs. It typically includes surgical drapes to create a sterile field for surgery. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
PHO	Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6238b2fe-82a2-49d4-b178-df08b425bed2
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 15, 2015