FDA.reportPublic FDA data

HeartWare® Controller DC Adapter

Primary DI
00888707000109
Brand
HeartWare® Controller DC Adapter
Company
Heartware Inc.
Model
1435
Catalog number
1435
Published
2014-08-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888707000109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888707000109008887070001098887070001090888707000109

GMDN Terms#

Term, Definition table
TermDefinition
Artificial heart, temporaryA sterile prosthetic device implanted in the thorax or abdomen that typically consists of an implantable metallic and plastic mechanism that includes one or more pumps working as artificial ventricles to circulate blood, and an electrical or air driven external power unit that is connected to the pumps through transcutaneous electrical wires or pneumatic drive-lines entering the patient's chest. The power unit is attached to the patient and includes a battery and/or a pneumatic console. This device is used mostly 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

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

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Primary DI, Brand, Company table
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00763000923655HeartWare™ BatteryHeartware, Inc.DSQ2026-05-01
07640135140153CentriMag™Thoratec CorporationDSQ2026-02-19
00763000989514HVAD™ ControllerHeartware Inc.DSQ2025-08-30
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05415067039903HeartMate™ GoGear™Thoratec CorporationDSQ2025-07-21
05415067039422HeartMate 3™Thoratec CorporationDSQ2025-07-16
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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