Home GUDID 05414734504539 Unify Quadra™
Primary DI 05414734504539
Brand Unify Quadra™
Company ST. JUDE MEDICAL, INC.
Model CD3249-40
Catalog number CD3249-40
Device description Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED 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
OTC false
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 05414734504539 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05414734504539 05414734504539 5414734504539
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)].
Device Sizes# Type, Value, Unit table Type Value Unit Total Volume 40 Milliliter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature -20 Degrees Celsius 60 Degrees Celsius Special Storage Condition, Specify 0 0 Store the device away from magnets and sources of electromagnetic interference. Storage Environment Temperature 10 Degrees Celsius 45 Degrees Celsius Storage Environment Temperature 50 Degrees Fahrenheit 113 Degrees Fahrenheit
Regulatory Flags# DUNS number 790268031 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05414734509138 NA ST. JUDE MEDICAL, INC. NIK 2026-03-04 05414734506380 NA ST. JUDE MEDICAL, INC. NIK 2025-12-22 05415067050045 Neutrino™ ST. JUDE MEDICAL, INC. NIK 2025-02-11 05415067050052 Gallant™ ST. JUDE MEDICAL, INC. NIK 2025-02-11 05415067050106 Entrant™ ST. JUDE MEDICAL, INC. NIK 2025-02-11 05415067049513 Entrant™ ST. JUDE MEDICAL, INC. NIK 2024-04-25 05415067049520 Gallant™ ST. JUDE MEDICAL, INC. NIK 2024-04-25 00802526589744 RESONATE™ HF CRT-D BOSTON SCIENTIFIC CORPORATION NIK 2021-07-12 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 04035479140144 Itrevia 5 HF-T QP BIOTRONIK SE & Co. KG NIK 2020-10-07 00763000059996 Compia MRI™ Quad CRT-D SureScan™ MEDTRONIC, INC. NIK 2020-09-04 00763000060091 Compia MRI™ CRT-D SureScan™ MEDTRONIC, INC. NIK 2020-09-04 05415067032010 Gallant™ ST. JUDE MEDICAL, INC. NIK 2020-09-02 05415067032850 Entrant™ ST. JUDE MEDICAL, INC. NIK 2020-09-02 00763000178178 Cobalt™ HF Quad CRT-D MRI SureScan™ MEDTRONIC, INC. NIK 2020-06-08 00763000178185 Cobalt™ HF Quad CRT-D MRI SureScan™ MEDTRONIC, INC. NIK 2020-06-08 00763000178215 Cobalt™ HF CRT-D MRI SureScan™ MEDTRONIC, INC. NIK 2020-06-08 00763000178222 Cobalt™ HF CRT-D MRI SureScan™ MEDTRONIC, INC. NIK 2020-06-08 00763000178253 Crome™ HF Quad CRT-D MRI SureScan™ MEDTRONIC, INC. NIK 2020-06-08 00763000178260 Crome™ HF Quad CRT-D MRI SureScan™ MEDTRONIC, INC. NIK 2020-06-08 00763000178291 Crome™ HF CRT-D MRI SureScan™ MEDTRONIC, INC. NIK 2020-06-08 00763000178307 Crome™ HF CRT-D MRI SureScan™ MEDTRONIC, INC. NIK 2020-06-08 00643169720732 Compia MRI™ CRT-D SureScan™ MEDTRONIC, INC. NIK 2019-10-14 04035479156725 Ilivia Neo 7 HF-T QP BIOTRONIK SE & Co. KG NIK 2019-09-10 04035479156732 Ilivia Neo 7 HF-T BIOTRONIK SE & Co. KG NIK 2019-09-10 04035479156824 Intica Neo 7 HF-T QP BIOTRONIK SE & Co. KG NIK 2019-09-10
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