Home GUDID 20653405059186 SURETRACE
Primary DI 20653405059186
Brand SURETRACE
Company Conmed Corporation
Model 1800C-005
Catalog number 1800C-005
Device description SURETRACE RTL, ADULT ECG ELECTRODE
Published 2016-09-24
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 20653405059186 Package GS1 600 In Commercial Distribution 10653405059189 Primary GS1 0 00653405059182 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 20653405059186 20653405059186 10653405059189 10653405059189 00653405059182 00653405059182 653405059182 0653405059182
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 Humidity 30 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Storage Environment Temperature 5 Degrees Celsius 35 Degrees Celsius Storage Environment Temperature 41 Degrees Fahrenheit 95 Degrees Fahrenheit
Regulatory Flags# DUNS number 071595540 Device count 600 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 false 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 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 08809083949129 TELECTRODE BIOPROTECH INC. DRX 2026-04-30 08809083949136 TELECTRODE BIOPROTECH INC. DRX 2026-04-30 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 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 08906035282881 Ambu WhiteSensor MEDICO ELECTRODES INTERNATIONAL LIMITED DRX 2020-08-20 08906035282898 Ambu WhiteSensor MEDICO ELECTRODES INTERNATIONAL LIMITED DRX 2020-08-20 08906035282904 Ambu WhiteSensor MEDICO ELECTRODES INTERNATIONAL LIMITED DRX 2020-08-20 08906035282911 Ambu WhiteSensor MEDICO ELECTRODES INTERNATIONAL LIMITED DRX 2020-08-20 08906035282942 Ambu WhiteSensor MEDICO ELECTRODES INTERNATIONAL LIMITED DRX 2020-08-20 08906035282959 Ambu WhiteSensor MEDICO ELECTRODES INTERNATIONAL LIMITED DRX 2020-08-20 08906035282966 Ambu WhiteSensor MEDICO ELECTRODES INTERNATIONAL LIMITED DRX 2020-08-20 08906035282980 Ambu WhiteSensor MEDICO ELECTRODES INTERNATIONAL LIMITED DRX 2020-08-20