Home GUDID 05415067032850 Entrant™
Primary DI 05415067032850
Brand Entrant™
Company ST. JUDE MEDICAL, INC.
Model CDHFA300Q
Catalog number CDHFA300Q
Device description HF Cardiac Resychronisation Therapy Defibrillator VVED DDDRV
Published 2020-09-02
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name NIK Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05415067032850 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05415067032850 05415067032850 5415067032850
GMDN Terms# Term, Definition table Term Definition Cardiac resynchronization therapy implantable defibrillator A sterile, 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 Handling Environment Temperature 10 Degrees Celsius 45 Degrees Celsius Handling Environment Temperature 15 Degrees Celsius 30 Degrees Celsius Handling Environment Temperature 50 Degrees Fahrenheit 113 Degrees Fahrenheit Handling Environment Temperature 59 Degrees Fahrenheit 86 Degrees Fahrenheit Special Storage Condition, Specify 0 0 Keep Dry. Keep Away from Sunlight. Protect From Heat and Radioactive Sources. Special Storage Condition, Specify 0 0 Storage excursions permitted from 59°- 86° F (15°- 30°C). Storage Environment Temperature 10 Degrees Celsius 45 Degrees Celsius Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius Storage Environment Temperature 22 Degrees Celsius 22 Degrees Celsius Storage Environment Temperature 50 Degrees Fahrenheit 113 Degrees Fahrenheit Storage Environment Temperature 59 Degrees Fahrenheit 86 Degrees Fahrenheit Storage Environment Temperature 72 Degrees Fahrenheit 72 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 04035479182809 Acticor Sky HF-T QP BIOTRONIK SE & Co. KG NIK 2026-04-20 04035479182816 Acticor Sky HF-T BIOTRONIK SE & Co. KG NIK 2026-04-20 04035479182854 Rivacor Sky HF-T QP BIOTRONIK SE & Co. KG NIK 2026-04-20 04035479182861 Rivacor Sky HF-T BIOTRONIK SE & Co. KG NIK 2026-04-20 04035479182984 Rivacor Aura HF-T QP BIOTRONIK SE & Co. KG NIK 2026-04-20 04035479182991 Rivacor Aura HF-T BIOTRONIK SE & Co. KG NIK 2026-04-20 04035479183028 Rivacor Rise HF-T QP BIOTRONIK SE & Co. KG NIK 2026-04-20 04035479183035 Rivacor Rise HF-T BIOTRONIK SE & Co. KG NIK 2026-04-20 05414734509138 NA ST. JUDE MEDICAL, INC. NIK 2026-03-04 05414734506380 NA ST. JUDE MEDICAL, INC. NIK 2025-12-22 05415067049575 Merlin™ ST. JUDE MEDICAL, INC. NIK 2025-06-25 05415067050045 Neutrino™ ST. JUDE MEDICAL, INC. NIK 2025-02-11 05415067050052 Gallant™ ST. JUDE MEDICAL, INC. NIK 2025-02-11 05415067050076 Neutrino™ ST. JUDE MEDICAL, INC. NIK 2025-02-11 05415067050090 Gallant™ ST. JUDE MEDICAL, INC. NIK 2025-02-11 05415067050106 Entrant™ ST. JUDE MEDICAL, INC. NIK 2025-02-11 05415067050120 Entrant™ ST. JUDE MEDICAL, INC. NIK 2025-02-11 05415067034809 Merlin@home™ ST. JUDE MEDICAL, INC. NIK 2024-11-13 05415067049513 Entrant™ ST. JUDE MEDICAL, INC. NIK 2024-04-25 05415067049520 Gallant™ ST. JUDE MEDICAL, INC. NIK 2024-04-25 05415067040404 NA ST. JUDE MEDICAL, INC. NIK 2023-01-09 05415067031174 Merlin™ ST. JUDE MEDICAL, INC. NIK 2022-08-29 05415067037121 Merlin™ ST. JUDE MEDICAL, INC. NIK 2022-08-29 00802526589744 RESONATE™ HF CRT-D BOSTON SCIENTIFIC CORPORATION NIK 2021-07-12 05415067032812 myMerlinPulse™ ST. JUDE MEDICAL, INC. NIK 2021-01-07 05415067032829 myMerlinPulse™ ST. JUDE MEDICAL, INC. NIK 2021-01-07 00763000178093 Cobalt™ XT HF Quad CRT-D MRI SureScan™ MEDTRONIC, INC. NIK 2020-11-22 00763000178109 Cobalt™ XT HF Quad CRT-D MRI SureScan™ MEDTRONIC, INC. NIK 2020-11-22 00763000178130 Cobalt™ XT HF CRT-D MRI SureScan™ MEDTRONIC, INC. NIK 2020-11-22 00763000178147 Cobalt™ XT HF CRT-D MRI SureScan™ MEDTRONIC, INC. NIK 2020-11-22
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