AccessGUDID - DEVICE: XVIVO Lung Cannula Set™ (07350069520098)

GUDID

Device Identifier (DI) Information

Brand Name: XVIVO Lung Cannula Set™
Version or Model: 19022
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 19022
Company Name: Xvivo Perfusion AB

Primary DI Number: 07350069520098
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 559895730 *Terms of Use

Device Description: XVIVO Lung Cannula Set™ is a sterile, single-use set intended to be used to connect isolated donor lungs to an extracorporeal perfusion system for ex-vivo assessment.

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 [?]
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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e1b8fd55-d9f4-49e1-8669-0d78cbd4f8bc
Public Version Date: December 22, 2021
Public Version Number: 4
DI Record Publish Date: October 15, 2015