GUDIDData
pma Primary ID: P920014

HEARTMATE XVE LEFT VENTRICULAR ASSIST SYSTEM (UDI P920014)

Manufactured by Thoratec Corp

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HEARTMATE XVE LEFT VENTRICULAR ASSIST SYSTEM - Primary ID P920014

Device Regulatory Overview

The HEARTMATE XVE LEFT VENTRICULAR ASSIST SYSTEM (Model/Catalog Number: Unspecified) is a medical device manufactured by Thoratec Corp. This product is indexed under FDA Product Code / Category Classification DSQ within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
N/A
Product Code / EMDN
DSQ
Device Name
Ventricular (assist) bypass
Database Sync Date
2026-08-09 10:04:44

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 HEARTMATE XVE LEFT VENTRICULAR ASSIST SYSTEM?

The registered manufacturer of record for HEARTMATE XVE LEFT VENTRICULAR ASSIST SYSTEM is Thoratec Corp.

What is the Primary UDI-DI identifier for HEARTMATE XVE LEFT VENTRICULAR ASSIST SYSTEM?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P920014.

What classification code is assigned to this device?

This device is registered under product classification code DSQ.

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