Home GUDID 10850018485019 EKG Patch™ (Large)
Primary DI 10850018485019
Brand EKG Patch™ (Large)
Company NULINE SENSORS, LLC
Model Large
Catalog number MGLRG
Device description Electrode, Electrocardiograph
Published 2020-07-01
Public version status New
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
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DRX Electrode, Electrocardiograph Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10850018485019 Package GS1 10 In Commercial Distribution 00850018485012 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 10850018485019 10850018485019 00850018485012 00850018485012 850018485012 0850018485012
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.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep Away from Light Special Storage Condition, Specify 0 0 Keep Dry Storage Environment Temperature 10 Degrees Celsius 27 Degrees Celsius
Regulatory Flags# DUNS number 079231054 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 true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850018485029 EKG Patch™ (Cable) Cable MGCBLSP 2020-07-01 00850018485005 EKG Patch™ (Medium) Medium MGMED 2020-07-01 00850018485012 EKG Patch™ (Large) Large MGLRG 2020-07-01 10850018485002 EKG Patch™ (Medium) Medium MGMED 2020-07-01
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 20885380213202 Kendall Cardinal Health 200, LLC DRX 2026-08-18 10850078465006 NIKOTRACE NIKOMED USA DRX 2026-08-17 10850078465013 NIKOTRACE NIKOMED USA DRX 2026-08-17 10850078465020 NIKOTRACE NIKOMED USA DRX 2026-08-17 05060038511034 Ambu® WhiteSensor 40554 Ambu A/S DRX 2026-08-07 00851491007555 AccuSensor Lynn Medical Instrument Co. DRX 2026-07-28 00851491007562 AccuSensor Lynn Medical Instrument Co. DRX 2026-07-24 G828HARNESS0 Physiotrace NimbleHeart, Inc. DRX 2026-05-28 G828PACKAGE0 Physiotrace NimbleHeart, Inc. DRX 2026-05-28 00860002238500 Piccolo Medical Piccolo Medical, Inc. DRX 2026-05-06 08809083949129 TELECTRODE BIOPROTECH INC. DRX 2026-04-30 08809083949136 TELECTRODE BIOPROTECH INC. DRX 2026-04-30 00860002238586 Piccolo Medical Piccolo Medical, Inc. DRX 2025-11-07 20192253016663 Kendall Cardinal Health 200, LLC DRX 2024-02-28 20192253016670 Kendall Cardinal Health 200, LLC DRX 2024-02-28 20192253017424 Kendall Cardinal Health 200, LLC DRX 2024-02-28 20192253017080 Kendall Cardinal Health 200, LLC DRX 2023-03-16 10841522130298 Eclipse Pro SPACELABS HEALTHCARE (WASHINGTON), INC DRX 2023-02-23 08033003267424 NA FIAB SPA DRX 2021-03-31 20192253016755 Kendall Cardinal Health 200, LLC DRX 2021-02-23 20192253017196 Kendall Cardinal Health 200, LLC DRX 2020-11-17 08906035281044 Ambu WhiteSensor MEDICO ELECTRODES INTERNATIONAL LIMITED DRX 2020-08-20 08906035281174 Ambu WhiteSensor MEDICO ELECTRODES INTERNATIONAL LIMITED DRX 2020-08-20 08906035281501 Ambu WhiteSensor MEDICO ELECTRODES INTERNATIONAL LIMITED DRX 2020-08-20 08906035281525 Ambu WhiteSensor MEDICO ELECTRODES INTERNATIONAL LIMITED DRX 2020-08-20 08906035281532 Ambu WhiteSensor MEDICO ELECTRODES INTERNATIONAL LIMITED DRX 2020-08-20 08906035281549 Ambu WhiteSensor MEDICO ELECTRODES INTERNATIONAL LIMITED DRX 2020-08-20 08906035281587 Ambu WhiteSensor MEDICO ELECTRODES INTERNATIONAL LIMITED DRX 2020-08-20 08906035281600 Ambu WhiteSensor MEDICO ELECTRODES INTERNATIONAL LIMITED DRX 2020-08-20 08906035282829 Ambu WhiteSensor MEDICO ELECTRODES INTERNATIONAL LIMITED DRX 2020-08-20
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