Home GUDID 05415067050106 Entrant™
Primary DI 05415067050106
Brand Entrant™
Company ST. JUDE MEDICAL, INC.
Model CDHFA300B
Catalog number CDHFA300B
Device description HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
Published 2025-02-11
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name DXY implantable pacemaker Pulse-generator LWO Pulse-generator, single chamber, sensor driven, implantable LWP Implantable pulse generator, pacemaker (non-CRT) LWS Implantable cardioverter defibrillator (non-CRT) NIK Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) NKE Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) NVN Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes PNJ Leadless pacemaker
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DXY Implantable Pacemaker Pulse-Generator Cardiovascular 3 LWO Pulse-Generator, Single Chamber, Sensor Driven, Implantable Unknown 3 LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown 3 LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown 3 NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown 3 NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown 3 NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown 3 PNJ Leadless Pacemaker Cardiovascular 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05415067050106 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05415067050106 05415067050106 5415067050106
GMDN Terms# Term, Definition table Term Definition Cardiac resynchronization therapy implantable defibrillator An implantable, battery-powered device consisting of a hermetically-sealed pacing pulse generator and an integrated defibrillation pulse generator with leads in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber). In addition to conventional pacing and defibrillation functions, the device is intended to provide cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions for more effective blood pumping to treat symptoms of heart failure (e.g., shortness of breath, easy fatigue) and serious heart-rhythm problems [CRT defibrillator (CRT-D)].
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature -20 Degrees Celsius 60 Degrees Celsius Handling Environment Temperature -4 Degrees Fahrenheit 140 Degrees Fahrenheit Special Storage Condition, Specify 0 0 Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius Storage Environment Temperature 59 Degrees Fahrenheit 86 Degrees Fahrenheit
Regulatory Flags# DUNS number 790268031 Device count 1 Serial number true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00643169634626 Azure™ XT SR MRI SureScan™ MEDTRONIC, INC. LWP 2017-12-02 00643169410961 CapSure Sense MRI™ SureScan™ MEDTRONIC, INC. NVN 2017-10-26 00643169448940 CapSure Sense MRI™ SureScan™ MEDTRONIC, INC. NVN 2017-10-26 00643169708686 Adapta™ L MEDTRONIC, INC. NVN 2017-10-20 00643169708686 Adapta™ L MEDTRONIC, INC. LWP 2017-10-20 00643169709041 Adapta™ MEDTRONIC, INC. NVN 2017-10-20 00643169709065 Sensia™ MEDTRONIC, INC. LWP 2017-10-20 00643169709072 Versa™ MEDTRONIC, INC. LWP 2017-10-20 00643169720138 Viva™ Quad XT CRT-D MEDTRONIC, INC. NIK 2017-09-15 00643169720190 Viva™ Quad XT CRT-D MEDTRONIC, INC. NIK 2017-09-15 00643169720251 Viva™ XT CRT-D MEDTRONIC, INC. NIK 2017-09-15 00643169720268 Viva™ S CRT-D MEDTRONIC, INC. NIK 2017-09-15 00643169720374 Evera™ XT DR MEDTRONIC, INC. LWS 2017-09-15 00643169720527 Evera MRI™ S DR SureScan® MEDTRONIC, INC. LWS 2017-09-15 00643169720558 Evera MRI™ XT VR SureScan® MEDTRONIC, INC. LWS 2017-09-15 00643169708624 Adapta™ MEDTRONIC, INC. LWP 2017-06-24 00643169708648 Adapta™ MEDTRONIC, INC. LWP 2017-06-24 00643169708662 Adapta™ MEDTRONIC, INC. LWP 2017-06-24 00643169708709 Adapta™ L MEDTRONIC, INC. LWP 2017-06-24 00643169708730 Adapta™ S MEDTRONIC, INC. LWP 2017-06-24 00643169708747 Adapta™ S MEDTRONIC, INC. LWP 2017-06-24 00643169708778 Adapta™ MEDTRONIC, INC. LWP 2017-06-24 00643169708808 Adapta™ MEDTRONIC, INC. LWP 2017-06-24 00643169708815 Adapta™ MEDTRONIC, INC. LWP 2017-06-24 00643169708891 Sensia™ MEDTRONIC, INC. LWP 2017-06-24 00643169453180 CapSureFix™ Novus MEDTRONIC, INC. NVN 2017-06-02 00643169633742 CapSureFix Novus MRI™ SureScan® MEDTRONIC, INC. NVN 2017-06-02 00643169633759 CapSureFix Novus MRI™ SureScan® MEDTRONIC, INC. NVN 2017-06-02 00643169633766 CapSureFix Novus MRI™ SureScan® MEDTRONIC, INC. NVN 2017-06-02 00643169410947 CapSure Sense MRI™ SureScan™ MEDTRONIC, INC. NVN 2017-02-05
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