FDA.reportPublic FDA data

THORATEC® PVAD™, ATRIAL CANNULA - SHORT, BEVELED TIP WITH SIDE HOLES

Primary DI
00813024012115
Brand
THORATEC® PVAD™, ATRIAL CANNULA - SHORT, BEVELED TIP WITH SIDE HOLES
Company
Thoratec Corporation
Model
10075-2574-001
Catalog number
10075-2574-001
Published
2014-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
00813024012115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813024012115008130240121158130240121150813024012115

GMDN Terms#

Term, Definition table
TermDefinition
External ventricular circulatory assist systemAn assembly of devices intended to assist a damaged or weakened heart (e.g., one affected by cardiogenic shock) to pump blood. It includes a mains electricity (AC-powered) external pump, an atrial or ventricular cannula to draw blood outside the body, a cannula to deliver the blood back to the aorta or pulmonary artery (depending on left or right ventricular assistance), and a unit that controls pump operation. It is typically intended to be used as a bridge to heart transplantation; it is not intended for cardiopulmonary bypass.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius30 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
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
07640135140153CentriMag™201-30500201-305002026-02-19
05415067034441CentriMag™1075331075332026-02-02
05415067038784HeartMate 3™10005877100058772025-07-21
05415067039446HeartMate 3™106531US106531US2025-07-21
05415067039880HeartMate™1061281061282025-07-21
05415067039903HeartMate™ GoGear™1061291061292025-07-21
05415067039422HeartMate 3™106531LF2106531LF22025-07-16
15415067037807HeartMate™246524652025-05-16
05415067037824HeartMate™144014402025-05-16
05415067038173HeartMate™ GoGear™1042321042322025-05-16
05415067038609HeartMate™1092001092002025-05-16
05415067038746HeartMate™105010502025-05-16
05415067039040HeartMate™236523652025-05-16
15415067039641HeartMate™286528652025-05-16
05415067039804HeartMate™ GoGear™1042301042302025-05-16
05415067039828HeartMate™ GoGear™1042311042312025-05-16
05415067038296HeartMate™10003491100034912025-04-02
15415067038279HeartMate™10002151100021512022-09-12
05415067042439CentriMag™CM2TR00CM2TR002022-08-30
05415067038760HeartMate 3™10005872100058722022-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000989514HVAD™ ControllerHeartware Inc.DSQ2025-08-30
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
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
05415067038296HeartMate™Thoratec CorporationDSQ2025-04-02
00763000629717HeartWare® BatteryHeartware Inc.DSQ2023-05-19
05415067038418HeartMate 3™ST. JUDE MEDICAL, INC.DSQ2022-09-27
15415067038279HeartMate™Thoratec CorporationDSQ2022-09-12
00888707009218HeartWare® Controller AC AdapterHeartware Inc.DSQ2022-08-15
00888707009256HeartWare® MonitorHeartware Inc.DSQ2022-08-15
00888707009935HeartWare® Controller DC AdapterHeartware Inc.DSQ2022-08-15
00888707009942HeartWare® BatteryHeartware Inc.DSQ2022-08-15
00888707010160Alarm Adapter Heartware Inc.DSQ2022-08-15
00888707010177Data Cable Heartware Inc.DSQ2022-08-15
05415067041654HeartMate 3™ST. JUDE MEDICAL, INC.DSQ2022-06-15
05415067038760HeartMate 3™Thoratec CorporationDSQ2022-06-14
05415067039286HeartMate 3™Thoratec CorporationDSQ2022-06-14
05415067039361HeartMate 3™Thoratec CorporationDSQ2022-06-14
15415067039481HeartMate 3™Thoratec CorporationDSQ2022-06-14