FDA.reportPublic FDA data

HeartMate™

Primary DI
15415067038279
Brand
HeartMate™
Company
Thoratec Corporation
Model
10002151
Catalog number
10002151
Device description
ICU Cover
Published
2022-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
P060040059

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P060040059THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEMABBOTT MEDICAL2008-04-21DSQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15415067038279PackageGS16In Commercial Distribution
00813024013495PreviousGS10
05415067038272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1541506703827915415067038279
00813024013495008130240134958130240134950813024013495
05415067038272054150670382725415067038272

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, reusableA patient-worn, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, strap, belt, or clothing. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius55 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius55 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
07640135140276CentriMag™201-50110201-501102022-03-29
07640135140283CentriMag™201-50112201-501122022-03-29
07640135140412CentriMag™201-50128201-501282022-03-29
07640135140429CentriMag™201-50129201-501292022-03-29
07640135140436CentriMag™201-50130201-501302022-03-29
07640135140443CentriMag™201-50131201-501312022-03-29
07640135140481CentriMag™201-50137201-501372022-03-29
07640135140566CentriMag™201-52213201-522132022-03-29
07640135140474CentriMag™1029611029612014-09-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000923594HeartWare™ MonitorMEDTRONIC, INC.DSQ2026-09-25
00763000923709Power CordMEDTRONIC, INC.DSQ2026-09-25
00763000923792Monitor Power CordMEDTRONIC, INC.DSQ2026-09-25
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