Home GUDID 05414734507905 Allure™
Primary DI 05414734507905
Brand Allure™
Company ST. JUDE MEDICAL, INC.
Model PM3222
Catalog number PM3222
Device description RF CRT Cardiac Resynchronization Therapy Pacemaker DDDRV
Published 2017-04-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 05414734507905 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05414734507905 05414734507905 5414734507905
GMDN Terms# Term, Definition table Term Definition Cardiac resynchronization therapy implantable pacemaker A sterile, battery-powered, hermetically-sealed pulse generator, intended to be implanted beneath the skin of the chest in a surgically-created pocket, and used with pacing leads placed in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber) to stimulate the heart to beat at a faster rate when it senses bradycardia and provides cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions to treat symptoms of heart failure (e.g., easy fatigue) and serious heart-rhythm problems [CRT pacemaker (CRT-P)]; it is not intended for defibrillation therapy.
Device Sizes# Type, Value, Unit table Type Value Unit Total Volume 14 Milliliter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature -20 Degrees Celsius 60 Degrees Celsius Handling Environment Temperature -5 Degrees Celsius 50 Degrees Celsius Handling Environment Temperature -4 Degrees Fahrenheit 140 Degrees Fahrenheit Handling Environment Temperature 23 Degrees Fahrenheit 122 Degrees Fahrenheit Special Storage Condition, Specify 0 0 Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. Storage Environment Temperature -5 Degrees Celsius 50 Degrees Celsius Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius Storage Environment Temperature 23 Degrees Fahrenheit 122 Degrees Fahrenheit 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 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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