Home GUDID 18809083941441 Vyaire
Primary DI 18809083941441
Brand Vyaire
Company Sunmed Group Holdings, LLC
Model 2009101-406
Device description Radiolucent Neonatal Cloth Monitoring Electrodes w/Preattached Lead wires (IEC version colors lead wires)
Published 2018-11-15
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 18809083941441 Package GS1 200 In Commercial Distribution 08809083941444 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 18809083941441 18809083941441 08809083941444 08809083941444 8809083941444
GMDN Terms# Term, Definition table Term Definition Electrocardiographic electrode, single-use A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -10 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 119058668 Device count 1 DM exempt false Premarket exempt false 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# 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 20192253016748 Kendall Cardinal Health 200, LLC DRX 2021-05-19 08033003267424 NA FIAB SPA DRX 2021-03-31 20192253016755 Kendall Cardinal Health 200, LLC DRX 2021-02-23 20192253017349 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