FDA.reportPublic FDA data

Quartet™

Primary DI
05414734510196
Brand
Quartet™
Company
ST. JUDE MEDICAL, INC.
Model
1457Q
Catalog number
1457Q
Device description
Left Heart Lead
Published
2025-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OJXDrug eluting permanent left ventricular (lv) pacemaker electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJXDrug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734510196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734510196054147345101965414734510196

GMDN Terms#

Term, Definition table
TermDefinition
Endocardial/interventricular septal pacing leadAn implantable wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may transmit intrinsic electrical activity from the heart back to the pulse generator. The electrode end is normally placed through a vein to contact the endocardium where it is fixed, or to penetrate the myocardium of the interventricular septum adjacent to the HIS-Purkinje system; the other end is connected to the pulse generator. It may be impregnated with a steroid intended to reduce inflammation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length92Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit
Special Storage Condition, Specify00Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F)
Storage Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
790268031
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414734008242Fast-Cath™4061044061042015-03-20
05414734008266Fast-Cath™4061204061202015-03-20
05414734008280Fast-Cath™4061284061282015-03-20
05414734008303Fast-Cath™4061404061402015-03-12
05414734008327Fast-Cath™4061624061622015-02-28
05414734008341Maximum™4062504062502015-04-11
05414734008365Maximum™4062514062512015-04-11
05414734008389Maximum™4062524062522015-04-11
05414734008402Maximum™4062534062532015-04-11
05414734008426Maximum™4062554062552015-04-10
05414734008488Maximum™4062594062592015-04-11
05414734008501Maximum™4063474063472015-04-11
05414734008525Maximum™4063594063592015-04-11
05414734008549Maximum™4063694063692015-04-10
05414734008563Fast-Cath™4065404065402015-02-28
05414734008587Fast-Cath™4065424065422015-02-28
05414734008600Fast-Cath™4065444065442015-02-28
05414734008648Maximum™4066534066532015-04-10
05414734008662Maximum™4066634066632015-04-10
05414734008808ULTIMUM™4078314078312015-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479138400Sentus ProMRI OTW QP S-75BIOTRONIK SE & Co. KGOJX2019-07-15
04035479138417Sentus ProMRI OTW QP S-85BIOTRONIK SE & Co. KGOJX2019-07-15
04035479138424Sentus ProMRI OTW QP S-95BIOTRONIK SE & Co. KGOJX2019-07-15
04035479138431Sentus ProMRI OTW QP L-75BIOTRONIK SE & Co. KGOJX2019-07-15
04035479138448Sentus ProMRI OTW QP L-85BIOTRONIK SE & Co. KGOJX2019-07-15
04035479138455Sentus ProMRI OTW QP L-95BIOTRONIK SE & Co. KGOJX2019-07-15
04035479145613Sentus ProMRI OTW QP S-95/49BIOTRONIK SE & Co. KGOJX2019-07-15
04035479148966Sentus ProMRI OTW QP L-95/49BIOTRONIK SE & Co. KGOJX2019-07-15
00643169860414Attain Stability™ Quad MRI SureScan™MEDTRONIC, INC.OJX2019-05-26
00643169860421Attain Stability™ Quad MRI SureScan™MEDTRONIC, INC.OJX2019-05-26
04035479145590Sentus ProMRI OTW QP S-75/49BIOTRONIK SE & Co. KGOJX2017-05-18
04035479145606Sentus ProMRI OTW QP S-85/49BIOTRONIK SE & Co. KGOJX2017-05-18
04035479148942Sentus ProMRI OTW QP L-75/49BIOTRONIK SE & Co. KGOJX2017-05-18
04035479148959Sentus ProMRI OTW QP L-85/49BIOTRONIK SE & Co. KGOJX2017-05-18
05414734502603Quickflex™ST. JUDE MEDICAL, INC.OJX2017-04-10
05414734502610Quickflex™ST. JUDE MEDICAL, INC.OJX2017-04-10
05414734502627Quickflex™ST. JUDE MEDICAL, INC.OJX2017-04-10
05414734506823SJM™ST. JUDE MEDICAL, INC.OJX2017-04-10
05414734510172Quartet™ST. JUDE MEDICAL, INC.OJX2017-03-30
05414734510189Quartet™ST. JUDE MEDICAL, INC.OJX2017-03-30
00643169860223Attain Ability™ Straight MRI SureScan™MEDTRONIC, INC.OJX2017-03-26
00643169860230Attain Ability™ Straight MRI SureScan™MEDTRONIC, INC.OJX2017-03-26
00643169860025Attain Ability™ MRI SureScan™MEDTRONIC, INC.OJX2017-03-24
00643169860032Attain Ability™ MRI SureScan™MEDTRONIC, INC.OJX2017-03-24
00643169860124Attain Ability™ Plus MRI SureScan™MEDTRONIC, INC.OJX2017-03-24
00643169860131Attain Ability™ Plus MRI SureScan™MEDTRONIC, INC.OJX2017-03-24
00643169601765Attain Ability™ MRI SureScan™MEDTRONIC, INC.OJX2016-02-26
00643169601772Attain Ability™ MRI SureScan™MEDTRONIC, INC.OJX2016-02-26
00643169601789Attain Ability™ Plus MRI SureScan™MEDTRONIC, INC.OJX2016-02-26
00643169601796Attain Ability™ Plus MRI SureScan™MEDTRONIC, INC.OJX2016-02-26