gudid
Primary ID: 19800
PERFADEX Plus (UDI 19800)
Manufactured by Xvivo Perfusion AB
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for PERFADEX Plus - Primary ID 19800
Device Regulatory Overview
The PERFADEX Plus (Model/Catalog Number: 19800) is a medical device manufactured by Xvivo Perfusion AB. This product is indexed under FDA Product Code / Category Classification KDN within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 19800
- Product Code / EMDN
- KDN
- Device Name
- Perfadex Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is intended for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.Package size: 10 x 1000ml
- 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 PERFADEX Plus?
The registered manufacturer of record for PERFADEX Plus is Xvivo Perfusion AB.
What is the Primary UDI-DI identifier for PERFADEX Plus?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 19800.
What classification code is assigned to this device?
This device is registered under product classification code KDN.
Similar Classification Devices (KDN)
Other Devices by Xvivo Perfusion AB
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