GUDIDData
pma Primary ID: P920014

TCI HEARTMATE 1000A IP LVAS (UDI P920014)

Manufactured by Thoratec Corp

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for TCI HEARTMATE 1000A IP LVAS - Primary ID P920014

Device Regulatory Overview

The TCI HEARTMATE 1000A IP LVAS (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 10:05:00

Full Regulatory Attributes

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{
    "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 TCI HEARTMATE 1000A IP LVAS?

The registered manufacturer of record for TCI HEARTMATE 1000A IP LVAS is Thoratec Corp.

What is the Primary UDI-DI identifier for TCI HEARTMATE 1000A IP LVAS?

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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