FDA.reportPublic FDA data

HeartWare® Battery

Primary DI
00888707002646
Brand
HeartWare® Battery
Company
Heartware Inc.
Model
1650DE
Catalog number
1650DE
Published
2018-03-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DSQVentricular (Assisst) Bypass

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100047000HEARTWARE VENTRICULAR ASSIST SYSTEMMedtronic2012-11-20DSQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888707002646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888707002646008887070026468887070026460888707002646

GMDN Terms#

Term, Definition table
TermDefinition
Implantable ventricular circulatory assist systemA portable assembly of devices intended to provide mechanical assistance to a heart ventricle(s), typically by pumping blood from the left ventricle to the aorta through an extra-cardiac circuit. It includes an implantable pump(s), connecting cannula/graft(s), a percutaneous lead, and external components (e.g., battery pack, controller). It is typically intended to be used as a bridge to heart transplantation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
146054536
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888707008204HVAD® Pump Surgical Tools131813182020-11-10
00888707008723HVAD® Pump Surgical Tools – Extended Length132813282020-11-10
00888707005388HVAD® Pump Surgical ToolsMCS1718STMCS1718ST2020-12-14
00763000989514HVAD™ ControllerMCS1421CN2025-08-30
00888707006880HeartWare® Controller DC Adapter144014402020-06-29
00888707000376HeartWare® Battery165016502015-06-24
00888707006859HVAD® Controller1403US1403US2019-10-07
00888707006866HeartWare® Controller AC Adapter1430US1430US2019-10-07
00888707006873HeartWare® Battery1650DE1650DE2019-10-07
00888707007641HVAD® Pump Outflow Graft112511252020-11-10
00888707008020Alarm Adapter145014502020-11-10
00888707008051Data Cable157515752020-11-10
00888707008778HeartWare® Battery1650DE1650DE2020-11-10
00888707009942HeartWare® Battery1650DE1650DE2022-08-15
00888707009041HVAD® Pump Implant KitMCS1705PUMCS1705PU2021-03-01
00888707005364HVAD® Pump Implant KitMCS1705PUMCS1705PU2020-12-14
00888707005371HVAD® Pump Implant AccessoriesMCS1753AKMCS1753AK2020-12-14
00888707007634HVAD® Pump Outflow GraftMCS1725OGMCS1725OG2020-12-14
00888707006897HeartWare® Battery1650DE1650DE2020-06-29
00888707000017HVAD® Pump Implant Kit (Enhanced)110311032014-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000923679HeartWare™ Waist PackHeartware, Inc.DSQ2026-05-31
00763000923686HeartWare™ Shoulder PackHeartware, Inc.DSQ2026-05-31
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