AccessGUDID - DEVICE: XVIVO Disposable Lung Kit (07350069520401)

GUDID

Device Identifier (DI) Information

Brand Name: XVIVO Disposable Lung Kit
Version or Model: 19046
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 19046
Company Name: Xvivo Perfusion AB

Primary DI Number: 07350069520401
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):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58267	Lung donor-organ preservation/evaluation system lung-interface set	A collection of disposable devices intended to be used with a lung donor-organ preservation/evaluation system to house, supply oxygen to, and/or manage preservation solution for, the preserved lung(s). It typically consists of the following components: a lung chamber, breathing circuit tubing, a configuration of fluid delivery tubing, a fluid reservoir, oxygenator components, filter(s), sensors, and may also include surgical drapes. This is a single-use device.	Active	false

FDA Product Code

[?]

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 [?]
P180014	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1b91da75-7a9d-499a-8ec9-039308a69650
Public Version Date: October 09, 2023
Public Version Number: 1
DI Record Publish Date: September 29, 2023