Home GUDID B146PE2C1 Universal CE electrode-patch
Primary DI B146PE2C1
Brand Universal CE electrode-patch
Company BRAEMAR MANUFACTURING, LLC
Model 02-01639
Published 2019-10-04
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name DRX Electrode, Electrocardiograph IKD Cable, Electrode
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DRX Electrode, Electrocardiograph Cardiovascular 2 IKD Cable, Electrode Physical Medicine 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B146PE2C1 Package HIBCC 40 In Commercial Distribution B146PE2C0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Ambulatory recorder conductive patch An adhesive patch intended to fix a patient-worn recorder (e.g., electrocardiographic long-term ambulatory recorder) to skin electrodes during long-term electrophysiological recording/monitoring [e.g., electrocardiogram (ECG)], and to transmit the electrical signals from the electrodes to the recorder. It is an electrical conducting patch made of metal and synthetic polymer materials. This is a single-use device.
Regulatory Flags# DUNS number 049529118 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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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