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enforcement Primary ID: Z-1106-2022

HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH (UDI Z-1106-2022)

Manufactured by Heartware, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH - Primary ID Z-1106-2022

Device Regulatory Overview

The HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH (Model/Catalog Number: Unspecified) is a medical device manufactured by Heartware, Inc.. This product is indexed under FDA Product Code / Category Classification GTIN 00888707002868, Serial Numbers: MON200197, MON200321, MON200668, MON200764 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.

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Technical Specifications

Model Number
N/A
Device Name
HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
Database Sync Date
2026-08-09 10:06:52

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 HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH?

The registered manufacturer of record for HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH is Heartware, Inc..

What is the Primary UDI-DI identifier for HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-1106-2022.

What classification code is assigned to this device?

This device is registered under product classification code GTIN 00888707002868, Serial Numbers: MON200197, MON200321, MON200668, MON200764.

Other Devices by Heartware, Inc.

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