ECG Electrodes

Philips Single-Patient-Use Disposable ECG Lead Sets are intended for use only by trained healthcare professionals for measurement of a patients ECG for both diagnostic and monitoring…

Registry build 21.09.26

Philips Single-Patient-Use Disposable ECG Lead Sets are intended for use only by trained healthcare professionals for measurement of a patients ECG for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. These Philips lead sets are intended for short-term use only (average patient stay of 5 days). Average lifetime of 5 days for disposable products.

22manufacturers in China registered for this device type
15catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (18), Jiangsu (1), Zhejiang (1). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DSA
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Ningbo Xinwell Medical Technology Co., Ltd. Cixi Zhejiang Contract manufacturer 12
APK Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 6
ABA Medical Technology Co Ltd Guang Dong Guangdong Contract manufacturer 6
Beijing Rongrui Century Science Technology Co., Ltd. Beijing Beijing Contract manufacturer 4
Dongguan Rongrui-Century Science&Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 4
Dongguan Ruibaolian Medical Science & Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 4
Dongguan Kepler Special Cabling Company Limited Dongguan Guangdong Contract manufacturer 3
Palconn Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 2
Shenzhen Redy-MED Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 2
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Edan Instruments, Inc. Shenzhen Guangdong Contract manufacturer 56

Showing 12 of 22. All 22 manufacturers in China registered for Cable, Transducer And Electrode, Patient, (Including Connector)

Record

Regulatory record for ECG Electrodes
Listed by Philips Medical Systems Hsg
FDA product code DSA
Device type Cable, Transducer And Electrode, Patient, (Including Connector)
Device class Class 2
Regulation 21 CFR 870.2900
Record published 2016-11-23
Record revised 2024-06-06 (version 11)

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries lot or batch number
Storage Storage environment temperature -40 to 70 °C; Storage environment temperature -40 to 158 °F; Storage environment atmospheric pressure 10 to 108 KiloPascal; Handling environment humidity 0 to 95 % RH
Distribution end date 2021-12-01

Catalogue Numbers

Catalogue numbers for ECG Electrodes
Catalogue number Size Per pack Status
6-LEAD SET, DISPOSABLE, BEDSIDE IEC 20 In distribution
SPU 6leadAAMI cable 20 In distribution
3 LEADS SET DISPOSABLE, BEDSIDE IEC RD 20 In distribution
5 LEADS SET DISPOSABLE, BEDSIDE IEC RD 20 In distribution
5 lead set Disposable, Bedside, AAMI 20 In distribution
3 lead set, Disposable, Bedside, AAMI 20 In distribution
5 lead set Disp., Telemetry, AAMI 20 In distribution
989803174501 Withdrawn
989803174511 Withdrawn
989803174521 Withdrawn
989803174531 Withdrawn
989803193821 Withdrawn
989803182171 Withdrawn
989803173141 Withdrawn
989803177881 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Unimed Unimed Medical Supplies Inc 5,928
AMC LifeSync Corporation 1,058
Fogg System Company, Inc. Fogg System Company, Inc. 693
Multi-Link™ AirLife Finland Oy 611
Cable, Transducer And Electrode, Patient, (Including Connector) ConMed Corporation 284
Maguire Maguire Enterprises, Inc. 193
MediChoice Owens & Minor Distribution, Inc. 160
Vermed Graphic Controls Acquisition Corporation 159
Vital Signs™ AirLife Finland Oy 136
Multi-Link™ Carefusion Finland 320 Oy 136
Med-link Shenzhen MED-Link Electronics Tech Co., Ltd. 129
Conmed ConMed Corporation 106

Showing 12 of 1,260. All products under Cable, Transducer And Electrode, Patient, (Including Connector)

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer