GUDIDData
eudamed_udi Primary ID: D-71278HH

ELUENT 80CV (UDI D-71278HH)

Manufactured by ARKRAY Factory, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ELUENT 80CV - Primary ID D-71278HH

Device Regulatory Overview

The ELUENT 80CV (Model/Catalog Number: 71278) is a medical device manufactured by ARKRAY Factory, Inc.. This product is indexed under FDA Product Code / Category Classification W01019001 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
71278
Product Code / EMDN
W01019001
Device Name
ELUENT 80CV
Database Sync Date
2026-08-09 16:28:50

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 ELUENT 80CV?

The registered manufacturer of record for ELUENT 80CV is ARKRAY Factory, Inc..

What is the Primary UDI-DI identifier for ELUENT 80CV?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-71278HH.

What classification code is assigned to this device?

This device is registered under product classification code W01019001.

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