XVIVO PGM Disposable Sensors™

Basic Information

• Brand Name: XVIVO PGM Disposable Sensors™
• Primary DI: 07350069520111
• Version / Model: 19033
• Catalog Number: 19033
• Company Name: Xvivo Perfusion AB
• Labeler DUNS: 559895730
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-15
• Public Version: 4
• Public Version Date: 2021-12-22
• Public Version Status: Update
• Public Device Record Key: f61daf29-05e7-4c33-ba64-7779d2ab88e4

Device Description

The XVIVO PGM Disposable Sensors™ are a single-use, disposable in-line sensor intended to be used with the XVIVO Perfusion System (XPS™) to monitor the pH and dissolved pO2 gas in STEEN Solution™ during ex-vivo lung assessment.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PHO	Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350069520111	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 50 Degrees Celsius