HeartMate, 14v Li-Ion Battery (SING) 102515-SING

GUDID 00813024012733

Thoratec Corporation

Secondary battery
Primary Device ID00813024012733
NIH Device Record Key8ae4440b-e1be-47cf-9450-0aeecb247ff3
Commercial Distribution Discontinuation2018-05-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameHeartMate, 14v Li-Ion Battery (SING)
Version Model Number102515-SING
Catalog Number102515-SING
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 -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100813024012733 [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 Date2019-03-21
Device Publish Date2015-08-06

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15415067039481 - HeartMate 3™2022-06-22 Thread Protectors
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