GUDIDData
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gudid Primary ID: H9382400-M

EXACTAMIX (UDI H9382400-M)

Manufactured by BAXTER HEALTHCARE CORPORATION

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for EXACTAMIX - Primary ID H9382400-M

Device Regulatory Overview

The EXACTAMIX (Model/Catalog Number: H9382400-M) is a medical device manufactured by BAXTER HEALTHCARE CORPORATION. This product is indexed under FDA Product Code / Category Classification NEP within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 2 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2174-2021 View Full Alert →

Kaguya Automated Peritoneal Dialysis System...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-2173-2021 View Full Alert →

Sharesource Connectivity Platform for Use with the Amia Automated PD System...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
H9382400-M
Product Code / EMDN
NEP
Device Name
EXACTAMIX Compounder, Main Module
Database Sync Date
2026-08-09 09:08:43

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 EXACTAMIX?

The registered manufacturer of record for EXACTAMIX is BAXTER HEALTHCARE CORPORATION.

What is the Primary UDI-DI identifier for EXACTAMIX?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is H9382400-M.

What classification code is assigned to this device?

This device is registered under product classification code NEP.

Similar Classification Devices (NEP)

Other Devices by BAXTER HEALTHCARE CORPORATION

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

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