FDA.reportPublic FDA data

THORATEC® HEARTMATE® XVE AND HEARTMATE II®, EMERGENCY POWER PACK

Primary DI
00813024010050
Brand
THORATEC® HEARTMATE® XVE AND HEARTMATE II®, EMERGENCY POWER PACK
Company
Thoratec Corporation
Model
2020VE
Catalog number
2020VE
Published
2017-07-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00813024010050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813024010050008130240100508130240100500813024010050

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
070156955
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640135140153CentriMag™201-30500201-305002026-02-19
05415067034441CentriMag™1075331075332026-02-02
05415067038784HeartMate 3™10005877100058772025-07-21
05415067039446HeartMate 3™106531US106531US2025-07-21
05415067039880HeartMate™1061281061282025-07-21
05415067039903HeartMate™ GoGear™1061291061292025-07-21
05415067039422HeartMate 3™106531LF2106531LF22025-07-16
15415067037807HeartMate™246524652025-05-16
05415067037824HeartMate™144014402025-05-16
05415067038173HeartMate™ GoGear™1042321042322025-05-16
05415067038609HeartMate™1092001092002025-05-16
05415067038746HeartMate™105010502025-05-16
05415067039040HeartMate™236523652025-05-16
15415067039641HeartMate™286528652025-05-16
05415067039804HeartMate™ GoGear™1042301042302025-05-16
05415067039828HeartMate™ GoGear™1042311042312025-05-16
05415067038296HeartMate™10003491100034912025-04-02
15415067038279HeartMate™10002151100021512022-09-12
05415067042439CentriMag™CM2TR00CM2TR002022-08-30
05415067038760HeartMate 3™10005872100058722022-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000989514HVAD™ ControllerHeartware Inc.DSQ2025-08-30
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
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
05415067038296HeartMate™Thoratec CorporationDSQ2025-04-02
00763000629717HeartWare® BatteryHeartware Inc.DSQ2023-05-19
05415067038418HeartMate 3™ST. JUDE MEDICAL, INC.DSQ2022-09-27
15415067038279HeartMate™Thoratec CorporationDSQ2022-09-12
00888707009218HeartWare® Controller AC AdapterHeartware Inc.DSQ2022-08-15
00888707009256HeartWare® MonitorHeartware Inc.DSQ2022-08-15
00888707009935HeartWare® Controller DC AdapterHeartware Inc.DSQ2022-08-15
00888707009942HeartWare® BatteryHeartware Inc.DSQ2022-08-15
00888707010160Alarm Adapter Heartware Inc.DSQ2022-08-15
00888707010177Data Cable Heartware Inc.DSQ2022-08-15
05415067041654HeartMate 3™ST. JUDE MEDICAL, INC.DSQ2022-06-15
05415067038760HeartMate 3™Thoratec CorporationDSQ2022-06-14
05415067039286HeartMate 3™Thoratec CorporationDSQ2022-06-14
05415067039361HeartMate 3™Thoratec CorporationDSQ2022-06-14
15415067039481HeartMate 3™Thoratec CorporationDSQ2022-06-14