HeartMate®, 14V Rechargeable Li-ion Battery 102515-US

GUDID 00813024012740

Thoratec Corporation

Secondary battery Secondary battery
Primary Device ID00813024012740
NIH Device Record Key7bc0467f-3d7b-4e61-a023-66c6ad700024
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeartMate®, 14V Rechargeable Li-ion Battery
Version Model Number102515-US
Catalog Number102515-US
Company DUNS070156955
Company NameThoratec Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100813024012740 [Primary]

FDA Product Code

DSQVentricular (Assisst) Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-06
Device Publish Date2015-08-06

Devices Manufactured by Thoratec Corporation

15415067038279 - HeartMate™2022-09-20 ICU Cover
05415067042439 - CentriMag™2022-09-07 System Transporter
05415067038760 - HeartMate 3™2022-06-22 Coring Tool
05415067039286 - HeartMate 3™2022-06-22 Apical Cuff
05415067039361 - HeartMate 3™2022-06-22 Skin Coring Punch
15415067039481 - HeartMate 3™2022-06-22 Thread Protectors
05415067033758 - HeartMate Touch™2020-07-02 Communication System
05415067032058 - HeartMate Touch™2020-05-12 Communication System

Trademark Results [HeartMate]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEARTMATE
HEARTMATE
76307678 not registered Dead/Abandoned
Thoratec Corporation
2001-08-31
HEARTMATE
HEARTMATE
73701099 1496671 Live/Registered
THERMEDICS INC.
1987-12-14

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