Home GUDID P00010 eWave Electrode Patch
Primary DI P00010
Brand eWave Electrode Patch
Company Wearlinq, Inc.
Model eWave Electrode Patch
Catalog number P0001
Device description Adhesive Electrode Patch
Published 2026-04-02
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Single use true Product Codes# Code, Name table Code Name DSH Recorder, Magnetic Tape, Medical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DSH Recorder, Magnetic Tape, Medical Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status P00010 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.
Device Sizes# Type, Value, Unit table Type Value Unit Length 87 Millimeter Width 62 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Handling Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Handling Environment Temperature 32 Degrees Fahrenheit 104 Degrees Fahrenheit Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature 32 Degrees Fahrenheit 104 Degrees Fahrenheit
Regulatory Flags# DUNS number 144863125 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published P00020 eWave Electrode Patch eWave Electrode Patch P0002 2026-07-14 K00010 eWave 6-Lead EKG eWave K0001 2026-04-02
Other Devices Sharing Product Codes# 
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