FDA.reportPublic FDA data

HeartWare™ Battery

Primary DI
00763000923655
Brand
HeartWare™ Battery
Company
Heartware, Inc.
Model
1650
Device description
BATTERY 1650MCS
Published
2026-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
P100047235

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100047235HEARTWARE VENTRICULAR ASSIST SYSTEMMedtronic2012-11-20DSQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000923655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000923655007630009236557630009236550763000923655

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
078661835
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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
00763000923679HeartWare™ Waist Pack20502026-05-31
00763000923686HeartWare™ Shoulder Pack20602026-05-31

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
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
05415067039323HeartMate 3™Thoratec CorporationDSQ2025-04-02