FDA.reportPublic FDA data

CentriMag™

Primary DI
07640135140566
Brand
CentriMag™
Company
Thoratec Corporation
Model
201-52213
Catalog number
201-52213
Device description
Mag Log Converter Software
Published
2022-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRIACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRIAccessory Equipment, Cardiopulmonary BypassCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640135140566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640135140566076401351405667640135140566

GMDN Terms#

Term, Definition table
TermDefinition
Circulatory assist system application softwareAn application data program designed for use in, or together with a circulatory assist system, so that this may function according to its intended purpose. This software program may be permanently installed or exchanged as an upgrade.

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
070156955
Device count
1
DM exempt
false
Premarket exempt
true
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
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
05415067038296HeartMate™10003491100034912025-04-02

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Primary DI, Brand, Company table
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08052595517465HOLDEREUROSETS SRLKRI2026-05-05
05060434424457QuantumSPECTRUM MEDICAL LIMITEDKRI2026-03-20
05060434424532QuantumSPECTRUM MEDICAL LIMITEDKRI2026-03-09
05415067034441CentriMag™Thoratec CorporationKRI2026-02-02
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08033178109857D100/D101SORIN GROUP ITALIA SRLKRI2023-10-24
08033178109864D130/D131 KIDS Arterial FilterSORIN GROUP ITALIA SRLKRI2023-10-24
08033178111959InspireSORIN GROUP ITALIA SRLKRI2023-10-24
08033178111966InspireSORIN GROUP ITALIA SRLKRI2023-10-24