GUDIDData
pma Primary ID: P180014

XVIVO Perfusion System (XPS) with STEEN Solution Perfusate (UDI P180014)

Manufactured by Xvivo Perfusion, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for XVIVO Perfusion System (XPS) with STEEN Solution Perfusate - Primary ID P180014

Device Regulatory Overview

The XVIVO Perfusion System (XPS) with STEEN Solution Perfusate (Model/Catalog Number: Unspecified) is a medical device manufactured by Xvivo Perfusion, Inc.. This product is indexed under FDA Product Code / Category Classification PHO within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
N/A
Product Code / EMDN
PHO
Device Name
Normothermic preservation system for transplantation of initially unacceptable donor lungs
Database Sync Date
2026-08-09 10:04:44

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of XVIVO Perfusion System (XPS) with STEEN Solution Perfusate?

The registered manufacturer of record for XVIVO Perfusion System (XPS) with STEEN Solution Perfusate is Xvivo Perfusion, Inc..

What is the Primary UDI-DI identifier for XVIVO Perfusion System (XPS) with STEEN Solution Perfusate?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P180014.

What classification code is assigned to this device?

This device is registered under product classification code PHO.

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