FDA.reportPublic FDA data

HEARTMATE®, SYSTEM MONITOR TO POWER MODULE CABLE

Primary DI
00813024010753
Brand
HEARTMATE®, SYSTEM MONITOR TO POWER MODULE CABLE
Company
Thoratec Corporation
Model
103859
Catalog number
103859
Published
2014-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00813024010753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813024010753008130240107538130240107530813024010753

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 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
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
false
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