GUDIDData
gudid Primary ID: D38595

DxU (UDI D38595)

Manufactured by Beckman Coulter, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for DxU - Primary ID D38595

Device Regulatory Overview

The DxU (Model/Catalog Number: D38595) is a medical device manufactured by Beckman Coulter, Inc.. This product is indexed under FDA Product Code / Category Classification JJW within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1922-2026 View Full Alert →

Access Total T4 Calibrator, Catalog No. 33805...

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ID: Z-2115-2025 View Full Alert →

Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850...

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ID: Z-1794-2026 View Full Alert →

MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative ...

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Technical Specifications

Model Number
D38595
Product Code / EMDN
JJW
Device Name
DxU Turbidity Control
Database Sync Date
2026-08-09 09:22:50

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 DxU?

The registered manufacturer of record for DxU is Beckman Coulter, Inc..

What is the Primary UDI-DI identifier for DxU?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D38595.

What classification code is assigned to this device?

This device is registered under product classification code JJW.

Programmatic Export

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