Home GUDID 00859244007296 WiSE CRT System
Primary DI 00859244007296
Brand WiSE CRT System
Company EBR Systems, Inc.
Model 5100
Device description Programmer
Published 2025-05-07
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 SEG Leadless Cardiac Resynchronization Therapy (Crt)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class SEG Leadless Cardiac Resynchronization Therapy (Crt) Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00859244007296 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00859244007296 00859244007296 859244007296 0859244007296
GMDN Terms# Term, Definition table Term Definition Cardiac pulse generator programmer An external device intended to enable a healthcare professional in a clinical setting to noninvasively change the settings of, and extract data from, an implanted cardiac pulse generator (e.g., pacemaker, pacemaker/defibrillator). It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Devices should be stored in their original packages in a dry, clean environment.
Regulatory Flags# DUNS number 151420580 Device count 1 Lot or batch true Serial number true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# 
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