Thoratec® Heartmate®, 11 Volt Li-Ion Backup Battery

FDA UDI

Class III (US FDA UDI)

by Thoratec Corp

Identity

Trade Name: THORATEC® HEARTMATE®, 11 VOLT LI-ION BACKUP BATTERY FDA UDI
Generic Name: Secondary battery FDA UDI
Model / Reference: 106128 FDA UDI

Identifiers

Catalog Number: 106128 FDA UDI
Primary DI / UDI-DI: 00813024011255 FDA UDI
FDA Product Code: DSQ FDA UDI
GMDN Term: Secondary battery FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Secondary battery

Thoratec® Heartmate®, 11 Volt Li-Ion Backup Battery by Thoratec Corp — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Thoratec Corp

Sources (1)

FDA UDI 4b98d36e-3323-49c5-ab0b-1c224cd8f779 35 fields · synced May 30, 2026