Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware HVAD controller DC Adapter Model 1440. Heartware HVAD data cable - monitor Model 1575. Heartware HVAD battery pack Models 1650, 1650CA-CLIN, and 1650DE. Heartware HVAD patient pack Model 1475. Heartware HVAD waist pack Models 2050, 2050IL, and 2050US. Heartware HVAD shoulder pack Models 2060, 2060IL, and 2060US. (UDI Z-1438-2021)

Manufactured by Heartware, Inc.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware HVAD controller DC Adapter Model 1440. Heartware HVAD data cable - monitor Model 1575. Heartware HVAD battery pack Models 1650, 1650CA-CLIN, and 1650DE. Heartware HVAD patient pack Model 1475. Heartware HVAD waist pack Models 2050, 2050IL, and 2050US. Heartware HVAD shoulder pack Models 2060, 2060IL, and 2060US. (Model/Catalog Number: Unspecified) is a medical device manufactured by Heartware, Inc.. This product is indexed under FDA Product Code / Category Classification Model, GTIN: 1100, No GTIN Available; 1101, No GTIN Available; 1102, No GTIN Available; 1103, 00888707000017; 1104, No GTIN Available; 1104JP, 00888707000697; 1205, No GTIN Available; MCS1705PU, 00888707005364; 1403US, 00888707000475; 1407AU, 00888707001663; 1407CA, 00888707002851; 1407CH, 00888707001694; 1407DE, 00888707001700; 1407GB, 00888707001717; 1407IL, 00888707001724; 1407IN, 00888707001731; 1407IT, 00888707001748; 1407JP, 00888707001755; 1407KR, 00888707001762; 1420, 00888707000420; 1420JP, 00888707000437; 1430AR, 00888707000826; 1430AU, 00888707000833; 1430CA, 00888707000857; 1430CH, 00888707000871; 1430DE, 00888707000864; 1430GB, 00888707000888; 1430IL, 00888707000901; 1430IN, 00888707000505; 1430IT, 00888707000895; 1430JP, 00888707000918; 1430US, 00888707000307; 1440, 00888707001885; 1575, 00888707008051; 1650, 00888707000376; 1650CA-CLIN, 00888707001588; 1650DE, 00888707001373; 1475, 00888707008037; 2050, 00888707008082; 2050IL, 00888707001410; 2050US, 00888707000048; 2060, 00888707008099; 2060IL, 00888707001427; 2060US, 00888707000055; 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...

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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...

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ID: Z-2793-2026 View Full Alert →

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

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Technical Specifications

Model Number: N/A
Product Code / EMDN: Model, GTIN: 1100, No GTIN Available; 1101, No GTIN Available; 1102, No GTIN Available; 1103, 00888707000017; 1104, No GTIN Available; 1104JP, 00888707000697; 1205, No GTIN Available; MCS1705PU, 00888707005364; 1403US, 00888707000475; 1407AU, 00888707001663; 1407CA, 00888707002851; 1407CH, 00888707001694; 1407DE, 00888707001700; 1407GB, 00888707001717; 1407IL, 00888707001724; 1407IN, 00888707001731; 1407IT, 00888707001748; 1407JP, 00888707001755; 1407KR, 00888707001762; 1420, 00888707000420; 1420JP, 00888707000437; 1430AR, 00888707000826; 1430AU, 00888707000833; 1430CA, 00888707000857; 1430CH, 00888707000871; 1430DE, 00888707000864; 1430GB, 00888707000888; 1430IL, 00888707000901; 1430IN, 00888707000505; 1430IT, 00888707000895; 1430JP, 00888707000918; 1430US, 00888707000307; 1440, 00888707001885; 1575, 00888707008051; 1650, 00888707000376; 1650CA-CLIN, 00888707001588; 1650DE, 00888707001373; 1475, 00888707008037; 2050, 00888707008082; 2050IL, 00888707001410; 2050US, 00888707000048; 2060, 00888707008099; 2060IL, 00888707001427; 2060US, 00888707000055;
Device Name: Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware HVAD controller DC Adapter Model 1440. Heartware HVAD data cable - monitor Model 1575. Heartware HVAD battery pack Models 1650, 1650CA-CLIN, and 1650DE. Heartware HVAD patient pack Model 1475. Heartware HVAD waist pack Models 2050, 2050IL, and 2050US. Heartware HVAD shoulder pack Models 2060, 2060IL, and 2060US.
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 Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware HVAD controller DC Adapter Model 1440. Heartware HVAD data cable - monitor Model 1575. Heartware HVAD battery pack Models 1650, 1650CA-CLIN, and 1650DE. Heartware HVAD patient pack Model 1475. Heartware HVAD waist pack Models 2050, 2050IL, and 2050US. Heartware HVAD shoulder pack Models 2060, 2060IL, and 2060US.?

The registered manufacturer of record for Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware HVAD controller DC Adapter Model 1440. Heartware HVAD data cable - monitor Model 1575. Heartware HVAD battery pack Models 1650, 1650CA-CLIN, and 1650DE. Heartware HVAD patient pack Model 1475. Heartware HVAD waist pack Models 2050, 2050IL, and 2050US. Heartware HVAD shoulder pack Models 2060, 2060IL, and 2060US. is Heartware, Inc..

What is the Primary UDI-DI identifier for Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware HVAD controller DC Adapter Model 1440. Heartware HVAD data cable - monitor Model 1575. Heartware HVAD battery pack Models 1650, 1650CA-CLIN, and 1650DE. Heartware HVAD patient pack Model 1475. Heartware HVAD waist pack Models 2050, 2050IL, and 2050US. Heartware HVAD shoulder pack Models 2060, 2060IL, and 2060US.?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-1438-2021.

What classification code is assigned to this device?

This device is registered under product classification code Model, GTIN: 1100, No GTIN Available; 1101, No GTIN Available; 1102, No GTIN Available; 1103, 00888707000017; 1104, No GTIN Available; 1104JP, 00888707000697; 1205, No GTIN Available; MCS1705PU, 00888707005364; 1403US, 00888707000475; 1407AU, 00888707001663; 1407CA, 00888707002851; 1407CH, 00888707001694; 1407DE, 00888707001700; 1407GB, 00888707001717; 1407IL, 00888707001724; 1407IN, 00888707001731; 1407IT, 00888707001748; 1407JP, 00888707001755; 1407KR, 00888707001762; 1420, 00888707000420; 1420JP, 00888707000437; 1430AR, 00888707000826; 1430AU, 00888707000833; 1430CA, 00888707000857; 1430CH, 00888707000871; 1430DE, 00888707000864; 1430GB, 00888707000888; 1430IL, 00888707000901; 1430IN, 00888707000505; 1430IT, 00888707000895; 1430JP, 00888707000918; 1430US, 00888707000307; 1440, 00888707001885; 1575, 00888707008051; 1650, 00888707000376; 1650CA-CLIN, 00888707001588; 1650DE, 00888707001373; 1475, 00888707008037; 2050, 00888707008082; 2050IL, 00888707001410; 2050US, 00888707000048; 2060, 00888707008099; 2060IL, 00888707001427; 2060US, 00888707000055;.

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