Home GUDID 09120073931962 Set of electrodes
Primary DI 09120073931962
Brand Set of electrodes
Company CNSystems Medizintechnik GmbH
Model V1.0
Catalog number 1616
Device description Set of 4ECG electrodes, 3 ICG electrodes and one grounding pad
Published 2018-10-04
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 DXN System, Measurement, Blood-Pressure, Non-Invasive
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 09120073931955 Package GS1 10 In Commercial Distribution 09120073931962 Package GS1 12 In Commercial Distribution 09120073931948 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09120073931955 09120073931955 9120073931955 09120073931962 09120073931962 9120073931962 09120073931948 09120073931948 9120073931948
GMDN Terms# Term, Definition table Term Definition Analytical non-scalp cutaneous electrode An electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to/from a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 30 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 40 Degrees Celsius Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Humidity 20 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature 0 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 300526077 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 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 06953825911942 Cofoe Shenzhen Urion Technology Co., Ltd DXN 2026-10-20 06953825911928 Cofoe Shenzhen Urion Technology Co., Ltd DXN 2026-10-19 06953825911904 saidian Shenzhen Urion Technology Co., Ltd DXN 2026-10-14 06974560230655 ziqing Shenzhen Ziqing Medical Equipment Co.,Ltd. DXN 2026-10-14 06953825911881 N/A Shenzhen Urion Technology Co., Ltd DXN 2026-10-13 06974560230648 ziqing Shenzhen Ziqing Medical Equipment Co.,Ltd. DXN 2026-10-13 00850078377302 iHealth iHealth Labs Inc. DXN 2026-10-12 00850078377326 iHealth iHealth Labs Inc. DXN 2026-10-12 06953825910501 arboleaf Shenzhen Urion Technology Co., Ltd DXN 2026-10-10 06933257920187 Electronic Blood Pressure Monitor JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. DXN 2026-10-09 06933257926066 YUWELL Electronic Blood Pressure Monitor JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. DXN 2026-10-09 06933257931688 YUWELL Electronic Blood Pressure Monitor JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. DXN 2026-10-09 06933257947016 YUWELL Electronic Blood Pressure Monitor JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. DXN 2026-10-09 06933257947023 Electronic Blood Pressure Monitor JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. DXN 2026-10-09 06933257947030 YUWELL Electronic Blood Pressure Monitor JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. DXN 2026-10-09 06973826012240 Agelh DONGGUAN E-TEST TECHNOLOGY CO.,LTD DXN 2026-10-09 06973826012257 Agelh DONGGUAN E-TEST TECHNOLOGY CO.,LTD DXN 2026-10-09 06973826012264 Agelh DONGGUAN E-TEST TECHNOLOGY CO.,LTD DXN 2026-10-09 06973826012271 Agelh DONGGUAN E-TEST TECHNOLOGY CO.,LTD DXN 2026-10-09 06973826012288 Agelh DONGGUAN E-TEST TECHNOLOGY CO.,LTD DXN 2026-10-09 06973826012295 Agelh DONGGUAN E-TEST TECHNOLOGY CO.,LTD DXN 2026-10-09 06973826012301 Agelh DONGGUAN E-TEST TECHNOLOGY CO.,LTD DXN 2026-10-09 06973826012318 Agelh DONGGUAN E-TEST TECHNOLOGY CO.,LTD DXN 2026-10-09 06973826012325 Agelh DONGGUAN E-TEST TECHNOLOGY CO.,LTD DXN 2026-10-09 06973826012332 Agelh DONGGUAN E-TEST TECHNOLOGY CO.,LTD DXN 2026-10-09 06973826012349 Agelh DONGGUAN E-TEST TECHNOLOGY CO.,LTD DXN 2026-10-09 06973826012356 Agelh DONGGUAN E-TEST TECHNOLOGY CO.,LTD DXN 2026-10-09 06973826012363 Agelh DONGGUAN E-TEST TECHNOLOGY CO.,LTD DXN 2026-10-09 06973826012370 Agelh DONGGUAN E-TEST TECHNOLOGY CO.,LTD DXN 2026-10-09 06973826012387 Agelh DONGGUAN E-TEST TECHNOLOGY CO.,LTD DXN 2026-10-09