FDA.reportPublic FDA data

Cardiac pulse generator reader, home-use

Definition
An external device intended to enable a layperson to noninvasively extract data from an implanted cardiac pulse generator (i.e., therapeutic active cardiac implant) to provide historic and/or current information on device performance, and may in addition be intended to communicate with a diagnostic cardiac implant (e.g., implantable cardiac monitor); it is not intended to program therapeutic implants and is dedicated to cardiac use. 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. This is a home-use device.
GUDID devices
82
Last updated
2026-08-03 17:34:01

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00763000862336MyCareLink™MEDTRONIC, INC.249552026-07-26
00763000367800MyCareLink™MEDTRONIC, INC.24950M2020-06-11
00763000367817MyCareLink™MEDTRONIC, INC.24950M2020-06-11
00763000367831MyCareLink™MEDTRONIC, INC.24950MZ2020-06-11
04035479159115CardioMessenger Smart 4G USBIOTRONIK SE & Co. KG4386132019-12-19
00763000612658MyCareLink™MEDTRONIC, INC.24950M2023-05-13
00763000612665MyCareLink™MEDTRONIC, INC.24950M2023-05-13
04035479177768CardioMessenger Smart 4G US mit WW ModemBIOTRONIK SE & Co. KG4706622022-05-04
00763000586225MyCareLink™MEDTRONIC, INC.24952C2022-01-31
00763000586232MyCareLink™MEDTRONIC, INC.24952C2022-01-31
00763000414023MyCareLink™MEDTRONIC, INC.24950M2021-02-07
00763000414030MyCareLink™MEDTRONIC, INC.24950M2021-02-07
00763000414047MyCareLink™MEDTRONIC, INC.24950M2021-02-07
00763000367886MyCareLink™MEDTRONIC, INC.249552020-12-26
00763000367893MyCareLink™MEDTRONIC, INC.249552020-12-26
04035479113391CardioMessenger -S KitBIOTRONIK SE & Co. KG3703282014-08-14
04035479113407CardioMessenger -S TLine KitBIOTRONIK SE & Co. KG3703292014-08-14
04035479136628CardioMessenger II LLT Kit USBIOTRONIK SE & Co. KG3997262014-08-14
04035479136635CardioMessenger II-S Kit GSM USBIOTRONIK SE & Co. KG3997292014-08-14
04035479136642CardioMessenger II-S Kit TLine USBIOTRONIK SE & Co. KG3997302014-08-14
00763000367824MyCareLink™MEDTRONIC, INC.24950M2020-07-10
00763000305079MyCareLink Smart™MEDTRONIC, INC.250002020-06-26
00763000180904NAMEDTRONIC, INC.PA970002020-06-21
00643169552272MyCareLink™MEDTRONIC, INC.24950L2019-08-11
00763000304942MyCareLink™MEDTRONIC, INC.24950LZ2020-03-16
00763000304959MyCareLink™MEDTRONIC, INC.24950LZ2020-03-16
00763000304966MyCareLink™MEDTRONIC, INC.24950LZ2020-03-16
00643169552043MyCareLink™MEDTRONIC, INC.24950L2019-10-13
00763000033194MyCareLink™MEDTRONIC, INC.24950L2019-10-13
00763000033217MyCareLink™MEDTRONIC, INC.24950L2019-10-13
00763000113988MyCareLink™MEDTRONIC, INC.24952B2019-05-12
00763000014384MyCareLink™MEDTRONIC, INC.24952A2017-11-19
00763000113797MyCareLink™MEDTRONIC, INC.24952B2018-06-16
00763000113995MyCareLink™MEDTRONIC, INC.24950LLQ2018-06-16
00763000114008MyCareLink™MEDTRONIC, INC.24950LLQ2018-10-29
00763000114015MyCareLink™MEDTRONIC, INC.24950LLQ2018-10-29
00721902290121NAMEDTRONIC, INC.20672014-09-23
00721902290138NAMEDTRONIC, INC.2067L2014-09-23
00721902825569InCheck™ AT PATIENT ASSISTANTMEDTRONIC, INC.9465AA2014-09-23
00681490501880NAMEDTRONIC, INC.9790XLA2014-09-23
00681490872843InCheck™ AT PATIENT ASSISTANTMEDTRONIC, INC.94652014-09-23
00643169191815MEDTRONIC CARELINK® MONITORMEDTRONIC, INC.2490C152014-09-23
00643169192058MEDTRONIC CARELINK EXPRESS™MEDTRONIC, INC.2020B32017-02-19
00643169312098CardioSight™ ReaderMEDTRONIC, INC.2020A22014-09-23
00643169312913CARELINK® MONITORMEDTRONIC, INC.2490H102014-09-23
00643169334717MEDTRONIC CARELINK® MONITORMEDTRONIC, INC.2490C152014-09-23
00643169341050MEDTRONIC CARELINK® MONITORMEDTRONIC, INC.2490C152014-09-23
00643169341067CARELINK® MONITORMEDTRONIC, INC.2490G232014-09-23
00643169341074CARELINK® MONITORMEDTRONIC, INC.2490H102014-09-23
00643169367203MyCareLink™MEDTRONIC, INC.24950D2014-09-23
00643169376823MEDTRONIC CARELINK® MONITORMEDTRONIC, INC.2490C162015-09-21
00643169402904CareLink® MonitorMEDTRONIC, INC.2490G232014-09-23
00643169441101MyCareLink™MEDTRONIC, INC.24950D2014-09-23
00643169452060MyCareLink™MEDTRONIC, INC.24950E2014-09-23
00643169459885CARELINK® MONITORMEDTRONIC, INC.2490G242014-10-03
00643169460089CarelinkMEDTRONIC, INC.2490G242015-04-14
00643169469884MyCareLink™MEDTRONIC, INC.249552014-10-31
00643169469891MyCareLink™MEDTRONIC, INC.249552014-10-31
00643169486744MyCareLink™MEDTRONIC, INC.24950D12014-09-23
00643169527539MyCareLink Smart™MEDTRONIC, INC.250002015-02-24
00643169552104MyCareLink™MEDTRONIC, INC.24950G2015-06-10
00643169552289MyCareLink™MEDTRONIC, INC.24950GLQ2015-06-10
00643169569744MyCareLink Smart™MEDTRONIC, INC.250002015-07-14
00643169571129N/AMEDTRONIC, INC.PA960002015-10-28
00643169657885MyCareLink™MEDTRONIC, INC.24950J2015-12-18
00643169658127MyCareLink™MEDTRONIC, INC.24950JLQ2016-01-04
00643169658134MyCareLink™MEDTRONIC, INC.24950JLQ2017-01-01
00643169666320MyCareLink Smart™MEDTRONIC, INC.250002016-04-30
00643169690943MEDTRONIC CARELINK® MONITORMEDTRONIC, INC.2490C172016-02-18
00643169705746MyCareLink™MEDTRONIC, INC.24950J2016-05-28
00643169705753MyCareLink™MEDTRONIC, INC.24950JLQ2016-05-28
00643169725195MyCareLink™MEDTRONIC, INC.24950K2017-05-01
00643169725362MyCareLink™MEDTRONIC, INC.24950KLQ2017-05-06
00643169725379MyCareLink™MEDTRONIC, INC.24950KLQ2017-11-16
00643169725386MyCareLink™MEDTRONIC, INC.24950KLQ2017-11-16
00643169947115MyCareLink™MEDTRONIC, INC.24950JLQ2017-04-06
00643169102095CARELINK® MONITORMEDTRONIC, INC.2490G212014-09-23
00643169102101CARELINK® MONITORMEDTRONIC, INC.2490H92014-09-23
00643169107052MEDTRONIC CARELINK EXPRESS™MEDTRONIC, INC.2020B22014-09-23
00613994381071CARELINK® MONITORMEDTRONIC, INC.2490J52014-09-23