GUDIDData
gudid Primary ID: 19033

XVIVO PGM Disposable Sensors (UDI 19033)

Manufactured by Xvivo Perfusion AB

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for XVIVO PGM Disposable Sensors - Primary ID 19033

Device Regulatory Overview

The XVIVO PGM Disposable Sensors (Model/Catalog Number: 19033) is a medical device manufactured by Xvivo Perfusion AB. This product is indexed under FDA Product Code / Category Classification PHO within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
19033
Product Code / EMDN
PHO
Device Name
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.
Database Sync Date
2026-08-09 09:48:57

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 PGM Disposable Sensors?

The registered manufacturer of record for XVIVO PGM Disposable Sensors is Xvivo Perfusion AB.

What is the Primary UDI-DI identifier for XVIVO PGM Disposable Sensors?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 19033.

What classification code is assigned to this device?

This device is registered under product classification code PHO.

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