gudid
Primary ID: 19004
STEEN Solution (UDI 19004)
Manufactured by Xvivo Perfusion AB
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for STEEN Solution - Primary ID 19004
Device Regulatory Overview
The STEEN Solution (Model/Catalog Number: 19004) 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
- 19004
- Product Code / EMDN
- PHO
- Device Name
- STEEN Solution is intended for assessment of isolated lungs after removal from the donor body for eventual transplantation into a recipient.
- Database Sync Date
- 2026-08-09 09:48:57
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of STEEN Solution?
The registered manufacturer of record for STEEN Solution is Xvivo Perfusion AB.
What is the Primary UDI-DI identifier for STEEN Solution?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 19004.
What classification code is assigned to this device?
This device is registered under product classification code PHO.
Similar Classification Devices (PHO)
Other Devices by Xvivo Perfusion AB
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