FDA.reportPublic FDA data

HeartMate 3™

Primary DI
05415067038456
Brand
HeartMate 3™
Company
Thoratec Corporation
Model
105581US
Catalog number
105581US
Device description
Sealed Outflow Graft with Bend Relief
Published
2025-04-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSQVentricular (assist) bypass

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160054091

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160054091HeartMate 3™ Left Ventricular Assist SystemABBOTT MEDICAL2017-08-23DSQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813024013266PreviousGS10
05415067038456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813024013266008130240132668130240132660813024013266
05415067038456054150670384565415067038456

GMDN Terms#

Term, Definition table
TermDefinition
Implantable ventricular circulatory assist system outflow cannula, animal-derivedAn implantable tube which includes animal-derived materials (e.g., synthetic polymer sealed with mammalian gelatin), intended to function as an outflow for an implantable ventricular circulatory assist system, to channel blood pumped from the left ventricle into the aorta via a surgically-created anastomosis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius35 Degrees Celsius
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
070156955
Device count
1
Lot or batch
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
05415067039323HeartMate 3™Thoratec CorporationDSQ2025-04-02
05415067038296HeartMate™Thoratec CorporationDSQ2025-04-02
05415067038234HeartMate™Thoratec CorporationDSQ2024-03-22