Home GUDID 05415067034809 Merlin@home™
Primary DI 05415067034809
Brand Merlin@home™
Company ST. JUDE MEDICAL, INC.
Model EX1150W
Catalog number EX1150W
Device description Transmitter
Published 2024-11-13
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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) NVZ Pulse generator, permanent, implantable OSR Pacemaker/icd/crt non-implanted components
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 NVZ Pulse Generator, Permanent, Implantable Unknown 3 OSR Pacemaker/Icd/Crt Non-Implanted Components Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05415067034809 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05415067034809 05415067034809 5415067034809
GMDN Terms# Term, Definition table Term Definition Transtelephonic implantable pacemaker analysis system An assembly of devices designed to analyse the performance of an implanted pacemaker based on electrocardiographic measurements that can be monitored transtelephonically. It typically includes a computer-based pacemaker analyser, a 12-lead electrocardiograph (ECG), and a transtelephonic receiver and/or transmitter. It provides data taken directly from the patient (e.g., ECG electrodes are applied to the patient and a test magnet is placed over the pacemaker to activate it) or a pacemaker programmer. Signals are sent to the receiver where pacemaker function information is displayed. This system may also include a database that collects and stores patient data.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature -25 Degrees Celsius 70 Degrees Celsius Handling Environment Temperature -13 Degrees Fahrenheit 158 Degrees Fahrenheit Storage Environment Temperature 10 Degrees Celsius 40 Degrees Celsius Storage Environment Temperature 50 Degrees Fahrenheit 104 Degrees Fahrenheit
Regulatory Flags# DUNS number 790268031 Device count 1 Serial number true Manufacturing 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 04035479190538 SW HMSC 3.66 BIOTRONIK SE & Co. KG OSR 2026-05-28 00643169720589 Evera MRI™ S VR SureScan® MEDTRONIC, INC. NVZ 2020-11-13 00643169552043 MyCareLink™ MEDTRONIC, INC. OSR 2019-10-13 00643169552272 MyCareLink™ MEDTRONIC, INC. NVZ 2019-08-11 00643169634589 Azure™ XT DR MRI SureScan™ MEDTRONIC, INC. NVZ 2017-12-02 00643169634602 Azure™ S DR MRI SureScan™ MEDTRONIC, INC. NVZ 2017-12-02 00643169634626 Azure™ XT SR MRI SureScan™ MEDTRONIC, INC. LWP 2017-12-02 00643169634640 Azure™ S SR MRI SureScan™ MEDTRONIC, INC. NVZ 2017-12-02 00643169725379 MyCareLink™ MEDTRONIC, INC. NVZ 2017-11-16 00643169708600 Adapta™ MEDTRONIC, INC. NVZ 2017-10-20 00643169708686 Adapta™ L MEDTRONIC, INC. LWP 2017-10-20 00643169709041 Adapta™ MEDTRONIC, INC. NVZ 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 00643169720404 Evera™ XT DR MEDTRONIC, INC. NVZ 2017-09-15 00643169720497 Evera MRI™ XT DR SureScan® MEDTRONIC, INC. NVZ 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 00643169720619 Visia AF™ VR MEDTRONIC, INC. NVZ 2017-09-15 00643169720626 Visia AF™ VR MEDTRONIC, INC. LWS 2017-09-15 00643169720794 Visia AF MRI™ 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
sjm.com