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Thoratec® HeartMate 3™

FDA UDI

Class III (US FDA UDI)

by Thoratec Corp

Identity

Trade Name
Thoratec® HeartMate 3™ FDA UDI
Generic Name
Implantable ventricular circulatory assist system control unit FDA UDI
Device Name
System Controller FDA UDI
Model / Reference
106531US FDA UDI
Description
System Controller FDA UDI

Identifiers

Catalog Number
106531US FDA UDI
Primary DI / UDI-DI
00813024013235 FDA UDI
FDA Product Code
DSQ FDA UDI
GMDN Term
Implantable ventricular circulatory assist system control unit FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Implantable ventricular circulatory assist system control unit

Thoratec® HeartMate 3™ by Thoratec Corp — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable ventricular circulatory assist system control unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Thoratec Corp

Sources (1)

  • FDA UDI e8e0a664-c1d2-4966-b652-01a6d119e83f 36 fields · synced May 30, 2026