AccessGUDID - DEVICE: XVIVO Perfusion System (XPS™) (07350069520104)

GUDID

Device Identifier (DI) Information

Brand Name: XVIVO Perfusion System (XPS™)
Version or Model: 19030
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 19030
Company Name: Xvivo Perfusion AB

Primary DI Number: 07350069520104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 559895730 *Terms of Use

Device Description: The XVIVO Perfusion System (XPS™) is indicated for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex-vivo function of the lungs can be reas-sessed for transplantation.

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
58266	Lung donor-organ preservation/evaluation system	An assembly of devices designed to be used for the reconditioning, ex-vivo evaluation and cold preservation of donated lungs prior to transplantation. It typically consists of a mains electricity (AC-powered) unit which includes an operator's console, a roller pump, monitor, heat exchanger unit and gas system. The lungs are placed in a disposable chamber where they are connected, via tubing, to the evaluation unit. Typically, measurements can be made of pulmonary pressure, temperature, and flow, with calculation of pulmonary vascular resistance. The system is intended for use in a hospital in a clean area and is mobile on wheels.	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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d1d0ddbc-e0b5-46c3-8953-fcc925b39564
Public Version Date: October 14, 2021
Public Version Number: 4
DI Record Publish Date: October 15, 2015