Home GUDID 05414734510080 Quadra Allure™
Primary DI 05414734510080
Brand Quadra Allure™
Company ST. JUDE MEDICAL, INC.
Model PM3542
Catalog number PM3542
Device description CRT Cardiac Resynchronization Therapy Pacemaker DDDRV
Published 2019-01-15
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 NKE Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05414734510080 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05414734510080 05414734510080 5414734510080
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 15 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 05415067049575 Merlin™ ST. JUDE MEDICAL, INC. NKE 2025-06-25 05415067050045 Neutrino™ ST. JUDE MEDICAL, INC. NKE 2025-02-11 05415067050052 Gallant™ ST. JUDE MEDICAL, INC. NKE 2025-02-11 05415067050076 Neutrino™ ST. JUDE MEDICAL, INC. NKE 2025-02-11 05415067050090 Gallant™ ST. JUDE MEDICAL, INC. NKE 2025-02-11 05415067050106 Entrant™ ST. JUDE MEDICAL, INC. NKE 2025-02-11 05415067050120 Entrant™ ST. JUDE MEDICAL, INC. NKE 2025-02-11 05415067034809 Merlin@home™ ST. JUDE MEDICAL, INC. NKE 2024-11-13 04035479174002 Amvia Edge HF-T QP BIOTRONIK SE & Co. KG NKE 2023-07-12 04035479174033 Amvia Sky HF-T BIOTRONIK SE & Co. KG NKE 2023-07-12 04035479174040 Amvia Sky HF-T QP BIOTRONIK SE & Co. KG NKE 2023-07-12 05415067040404 NA ST. JUDE MEDICAL, INC. NKE 2023-01-09 00763000688479 NA MEDTRONIC, INC. NKE 2022-10-28 05415067031174 Merlin™ ST. JUDE MEDICAL, INC. NKE 2022-08-29 05415067037121 Merlin™ ST. JUDE MEDICAL, INC. NKE 2022-08-29 05414734510097 Quadra Allure MP™ ST. JUDE MEDICAL, INC. NKE 2019-01-15 00763000060428 NA MEDTRONIC, INC. NKE 2018-12-16 00643169891401 Percepta™ CRT-P MRI SureScan™ MEDTRONIC, INC. NKE 2017-10-20 00643169891418 Percepta™ Quad CRT-P MRI SureScan™ MEDTRONIC, INC. NKE 2017-10-20 00643169891425 Serena™ CRT-P MRI SureScan™ MEDTRONIC, INC. NKE 2017-10-20 00643169891432 Serena™ Quad CRT-P MRI SureScan™ MEDTRONIC, INC. NKE 2017-10-20 00643169891449 Solara™ CRT-P MRI SureScan™ MEDTRONIC, INC. NKE 2017-10-20 00643169891456 Solara™ Quad CRT-P MRI SureScan™ MEDTRONIC, INC. NKE 2017-10-20 00643169735637 Percepta™ CRT-P MRI SureScan™ MEDTRONIC, INC. NKE 2017-06-18 00643169735644 Percepta™ Quad CRT-P MRI SureScan™ MEDTRONIC, INC. NKE 2017-06-18 00643169735651 Serena™ CRT-P MRI SureScan™ MEDTRONIC, INC. NKE 2017-06-18 00643169735668 Serena™ Quad CRT-P MRI SureScan™ MEDTRONIC, INC. NKE 2017-06-18 00643169735675 Solara™ CRT-P MRI SureScan™ MEDTRONIC, INC. NKE 2017-06-18 00643169735682 Solara™ Quad CRT-P MRI SureScan™ MEDTRONIC, INC. NKE 2017-06-18 00643169855519 NA MEDTRONIC, INC. NKE 2017-05-25
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