Home GUDID 05415067046468 AVEIR™
Primary DI 05415067046468
Brand AVEIR™
Company ST. JUDE MEDICAL, INC.
Model LSRMC01
Catalog number LSRMC01
Device description Patient Transmitter Wired Electrodes
Published 2024-12-11
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name PNJ Leadless pacemaker
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PNJ Leadless Pacemaker Cardiovascular 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05415067046468 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05415067046468 05415067046468 5415067046468
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 Humidity 0 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Handling Environment Temperature -25 Degrees Celsius 60 Degrees Celsius Handling Environment Temperature -13 Degrees Fahrenheit 140 Degrees Fahrenheit Special Storage Condition, Specify 0 0 Keep dry. Keep away from sunlight. Protect from heat and radioactive sources Storage Environment Humidity 0 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature -25 Degrees Celsius 60 Degrees Celsius Storage Environment Temperature -13 Degrees Fahrenheit 140 Degrees Fahrenheit
Regulatory Flags# DUNS number 790268031 Device count 1 Lot or batch 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 05415067051189 AVEIR™ ST. JUDE MEDICAL, INC. PNJ 2025-08-07 05415067050045 Neutrino™ ST. JUDE MEDICAL, INC. PNJ 2025-02-11 05415067050052 Gallant™ ST. JUDE MEDICAL, INC. PNJ 2025-02-11 05415067050076 Neutrino™ ST. JUDE MEDICAL, INC. PNJ 2025-02-11 05415067050090 Gallant™ ST. JUDE MEDICAL, INC. PNJ 2025-02-11 05415067050106 Entrant™ ST. JUDE MEDICAL, INC. PNJ 2025-02-11 05415067050120 Entrant™ ST. JUDE MEDICAL, INC. PNJ 2025-02-11 05415067049971 AVEIR™ ST. JUDE MEDICAL, INC. PNJ 2024-12-12 05415067046475 AVEIR™ ST. JUDE MEDICAL, INC. PNJ 2024-12-11 05415067040701 Aveir™ ST. JUDE MEDICAL, INC. PNJ 2023-09-12 05415067040725 Aveir™ ST. JUDE MEDICAL, INC. PNJ 2023-09-12 05415067038487 Aveir™ ST. JUDE MEDICAL, INC. PNJ 2023-08-15 00763000078645 Micra™ AV2 MEDTRONIC, INC. PNJ 2023-05-05 00763000078683 Micra™ VR2 MEDTRONIC, INC. PNJ 2023-05-05 05415067031914 Aveir™ ST. JUDE MEDICAL, INC. PNJ 2023-03-03 05415067034472 Aveir™ ST. JUDE MEDICAL, INC. PNJ 2023-03-03 05415067036384 Aveir™ ST. JUDE MEDICAL, INC. PNJ 2023-03-03 00763000078621 Micra™ AV MEDTRONIC, INC. PNJ 2020-02-02 00643169711761 Micra™ MEDTRONIC, INC. PNJ 2018-01-13 05414734509732 Merlin.net ST. JUDE MEDICAL, INC. PNJ 2016-05-04 00643169529748 Micra™ MEDTRONIC, INC. PNJ 2016-04-18 05414734509725 Merlin™ ST. JUDE MEDICAL, INC. PNJ 2016-01-27
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