Home GUDID B146BTPA10 BTP-1000A
Primary DI B146BTPA10
Brand BTP-1000A
Company BRAEMAR MANUFACTURING, LLC
Model 02-00143
Published 2020-07-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name DSI Detector And Alarm, Arrhythmia IKD Cable, Electrode
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DSI Detector And Alarm, Arrhythmia Cardiovascular 2 IKD Cable, Electrode Physical Medicine 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B146BTPA10 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Electrocardiographic ambulatory recorder An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).
Regulatory Flags# DUNS number 049529118 Device count 1 Premarket exempt true Serial number true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00884838128729 C6 Monitor A13, Verizon 02-02386 2025-10-06 00884838128736 C6 Monitor A13, T Mobile 02-02387 2025-10-06 B146C6R30 C6 Sensor 3.0, Rebuilt 02-02124 2024-06-26 B146EP25R0 ePatch Sensor 2.5, Rebuilt 02-02251 2024-06-26 B146C6M20 C6 Monitor UGW 100-0048-02 2019-10-08 B146EP2510 ePatch 2.5, BTH 02-02045 2023-01-20 B146EP2520 ePatch 2.5, BTI 02-02046 2023-11-22 B146C6M60 C6 Monitor A10e, Sprint 02-01800 2023-06-15 B146C6M80 C6 Monitor A13, T Mobile 02-02119 2023-06-15 B146C6M90 C6 Monitor A13, Verizon 02-02118 2023-06-15 B146EP2R10 ePatch 2.0 rebuilt 02-01997 2022-07-13 B146C6M70 C6 Monitor A10e, Verizon 02-01804 2022-03-21 B146C6E10 C6 Sensor 3.0 02-01846 2021-04-28 B146C6R10 C6 Sensor 2.5 rebuilt 02-01889 2021-03-30 B146C6R20 C6 Sensor 2.0 rebuilt 02-01897 2021-03-30 B146BTPM0 BTP-1000S Monitor 100-0045-02 2020-07-15 B146C6M40 C6 Monitor 02-01549 2020-07-15 B146EP2020 ePatch 2.0 BTI 02-01650 2020-07-15 B146C6D0 C6 Sensor D 02-01561 2019-10-08 B146C6D10 C6 Sensor 02-01606 2019-10-10
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