GUDIDData
Bulk Audit Tool API Access
enforcement Primary ID: Z-0743-2023

HeartWare Model 1101 (UDI Z-0743-2023)

Manufactured by Heartware, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HeartWare Model 1101 - Primary ID Z-0743-2023

Device Regulatory Overview

The HeartWare Model 1101 (Model/Catalog Number: Unspecified) is a medical device manufactured by Heartware, Inc.. This product is indexed under FDA Product Code / Category Classification Serial Numbers: HW1146, HW1205, HW1209, HW1247, HW1454, HW1533, HW1634, HW1688, HW1951, HW200, HW281, HW378, HW383, HW469, HW492, HW557, HW816, HW933, HW1091, HW1143, HW1144, HW1200, HW1242, HW1243, HW1244, HW1276, HW1280, HW1398, HW1403, HW1415, HW1437, HW1439, HW1456, HW1524, HW1553, HW1555, HW1637, HW1694, HW1697, HW1769, HW1816, HW1818, HW1963, HW198, hw209, HW229, HW257, HW290, HW304, HW310, HW321, HW323, HW433, HW467, HW482, HW488, HW536, HW562, HW568, HW578, HW581, HW590, HW591, HW610, HW635, HW645, HW678, HW795, HW796, HW798, HW801, HW819, HW825, HW827, HW888, HW889, HW922, HW978, HW107, HW210, HW216, HW526 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-2753-2026 View Full Alert →

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-2755-2026 View Full Alert →

FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, I...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-2793-2026 View Full Alert →

SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System...

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

Technical Specifications

Model Number
N/A
Device Name
HeartWare Model 1101
Database Sync Date
2026-08-09 10:06:36

Full Regulatory Attributes

🔒 Token Gated 
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of HeartWare Model 1101?

The registered manufacturer of record for HeartWare Model 1101 is Heartware, Inc..

What is the Primary UDI-DI identifier for HeartWare Model 1101?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-0743-2023.

What classification code is assigned to this device?

This device is registered under product classification code Serial Numbers: HW1146, HW1205, HW1209, HW1247, HW1454, HW1533, HW1634, HW1688, HW1951, HW200, HW281, HW378, HW383, HW469, HW492, HW557, HW816, HW933, HW1091, HW1143, HW1144, HW1200, HW1242, HW1243, HW1244, HW1276, HW1280, HW1398, HW1403, HW1415, HW1437, HW1439, HW1456, HW1524, HW1553, HW1555, HW1637, HW1694, HW1697, HW1769, HW1816, HW1818, HW1963, HW198, hw209, HW229, HW257, HW290, HW304, HW310, HW321, HW323, HW433, HW467, HW482, HW488, HW536, HW562, HW568, HW578, HW581, HW590, HW591, HW610, HW635, HW645, HW678, HW795, HW796, HW798, HW801, HW819, HW825, HW827, HW888, HW889, HW922, HW978, HW107, HW210, HW216, HW526.

Other Devices by Heartware, Inc.

Programmatic Export

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

JSON API Endpoint