FDA.reportPublic FDA data

THORATEC® HEARTMATE® XVE AND HEARTMATE II®, BATTERY MODULE

Primary DI
00813024010128
Brand
THORATEC® HEARTMATE® XVE AND HEARTMATE II®, BATTERY MODULE
Company
Thoratec Corporation
Model
1264
Catalog number
1264
Published
2014-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSQVentricular (Assisst) Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSQVentricular (Assist) BypassUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813024010128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813024010128008130240101288130240101280813024010128

GMDN Terms#

Term, Definition table
TermDefinition
Primary batteryA non-rechargeable set of electrochemical cells, or a single cell, designed to store chemical energy and release it in the form of electrical energy to provide power for active implantable medical devices or external medical instruments, for backup power for programmable devices that must retain electronic information, or to power portable or other medical devices when it is not possible or convenient to use the line supply. The device includes terminals and may include a case. The size, shape, and chemical composition of the device should be specified according to the requirements in "IEC 60086-1 Primary batteries - Part 1: General", or the latest version of this standard.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
070156955
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067038272HeartMate™10002151100021512022-09-12
05415067039606HeartMate™126012602025-05-16
05415067039781HeartMate™ GoGear™1042291042292025-05-16
05415067039842HeartMate™ GoGear™1042331042332025-05-16
05415067039866HeartMate™ GoGear™1042341042342025-05-16
05415067039927HeartMate™ GoGear™1064491064492025-05-16
05415067039903HeartMate™ GoGear™1061291061292025-07-21
05415067039422HeartMate 3™106531LF2106531LF22025-07-16
05415067038173HeartMate™ GoGear™1042321042322025-05-16
05415067039804HeartMate™ GoGear™1042301042302025-05-16
05415067039828HeartMate™ GoGear™1042311042312025-05-16
05415067038296HeartMate™10003491100034912025-04-02
00813024013495Thoratec® HeartMate® ICU Cover (6 Pack)10002151100021512019-05-14
00813024010456THORATEC® HEARTMATE® GOGEAR®, SHOWER BAG1042161042162014-09-20
00813024010463THORATEC® HEARTMATE® GOGEAR®, HOLSTER VEST, SMALL1042171042172014-09-20
00813024010470THORATEC® HEARTMATE® GOGEAR®, HOLSTER VEST, MEDIUM1042181042182014-09-20
00813024010487THORATEC® HEARTMATE® GOGEAR®, HOLSTER VEST, LARGE1042191042192014-09-20
00813024010494THORATEC® HEARTMATE® GOGEAR®, MODULAR BELT, SMALL-MEDIUM1042201042202014-09-20
00813024010500THORATEC® HEARTMATE® GOGEAR®, MODULAR BELT, LARGE1042211042212014-09-20
00813024010555THORATEC® HEARTMATE®, TRAVEL BAG126012602014-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000923655HeartWare™ BatteryHeartware, Inc.DSQ2026-05-01
07640135140153CentriMag™Thoratec CorporationDSQ2026-02-19
00763000989514HVAD™ ControllerHeartware Inc.DSQ2025-08-30
05415067039385HeartMate 3™Thoratec CorporationDSQ2025-07-21
05415067039545HeartMate™Thoratec CorporationDSQ2025-07-21
05415067038784HeartMate 3™Thoratec CorporationDSQ2025-07-21
05415067039446HeartMate 3™Thoratec CorporationDSQ2025-07-21
05415067039880HeartMate™Thoratec CorporationDSQ2025-07-21
05415067039903HeartMate™ GoGear™Thoratec CorporationDSQ2025-07-21
05415067039422HeartMate 3™Thoratec CorporationDSQ2025-07-16
05415067037800HeartMate™Thoratec CorporationDSQ2025-05-16
05415067038821HeartMate 3™Thoratec CorporationDSQ2025-05-16
05415067039606HeartMate™Thoratec CorporationDSQ2025-05-16
05415067039644HeartMate™Thoratec CorporationDSQ2025-05-16
05415067039781HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
05415067039842HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
05415067039866HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
05415067039927HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
15415067037807HeartMate™Thoratec CorporationDSQ2025-05-16
05415067037824HeartMate™Thoratec CorporationDSQ2025-05-16
05415067038173HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
05415067038609HeartMate™Thoratec CorporationDSQ2025-05-16
05415067038746HeartMate™Thoratec CorporationDSQ2025-05-16
05415067039040HeartMate™Thoratec CorporationDSQ2025-05-16
15415067039641HeartMate™Thoratec CorporationDSQ2025-05-16
05415067039804HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
05415067039828HeartMate™ GoGear™Thoratec CorporationDSQ2025-05-16
05415067038456HeartMate 3™Thoratec CorporationDSQ2025-04-07
05415067039323HeartMate 3™Thoratec CorporationDSQ2025-04-02
05415067038296HeartMate™Thoratec CorporationDSQ2025-04-02