Cable, Electrode

ECG Leadwire SET, 5-LD Grouped, Snap, IEC, 130 CM/ 51 IN

Registry build 21.09.26
47manufacturers in China registered for this device type
103catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (31), Jiangsu (4), Shandong (3). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IKD
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Amphenol Alden Products Company Shenzhen Guangdong Contract manufacturer 24
Shenzhen Dongdixin Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
Shenzhen MED-Link Electronics Tech Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
ATL Technology DG,Ltd. Dongguan Guangdong Contract manufacturer 14
Shenzhen Caremed Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Pine Moon Electronics Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
ABA Medical Technology Co Ltd Guang Dong Guangdong Contract manufacturer 6
Tasco Medical Industries Co., Ltd. Bao An District, Shenzhen Guangdong Contract manufacturer 6
Beijing Rongrui Century Science Technology Co., Ltd. Beijing Beijing 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

Showing 12 of 47. All 47 manufacturers in China registered for Cable, Electrode

Record

Regulatory record for Cable, Electrode
Listed by GE Healthcare Finland OY, Finland
FDA product code IKD
Device type Cable, Electrode
Device class Class 2
Regulation 21 CFR 890.1175
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2018-08-10
Record revised 2024-06-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number
Distribution end date 2025-08-22

Catalogue Numbers

Catalogue numbers for Cable, Electrode
Catalogue number Size Status
ECG Leadwire set, 3-lead, grabber, AHA, 74 cm/ 29 in In distribution
ECG TRUNK CABLE, 6-LEAD, IEC, 1.2 M/4 FT In distribution
ECG Leadwire set, 6-lead, grouped, grabber, AHA, 130 cm/ 51 in In distribution
Invasive Blood Pressure Cable, ICU Medical Transpac-IV, Dual, 3.6 m/12 ft. In distribution
Invasive Blood Pressure Cable, ICU Medical Transpac-IV, Single, 3.6 m/12 ft. In distribution
Invasive Blood Pressure Cable, Utah/Biotrans, Dual 3.6 m/12 ft. In distribution
ECG Leadwire set, telemetry, 5-lead, snap, AHA, 27 in In distribution
ECG Leadwire set, 5-lead, grouped, grabber, AHA, 130 cm/ 51 in In distribution
ECG TRUNK CABLE, 3/5-LEAD W/ESU FILTER, IEC, 3.6 M/12 FT In distribution
ECG Leadwire set, 5-lead, grouped, snap, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in In distribution
ECG TRUNK CABLE, 12-LEAD, IEC, 3.6 M/12 FT In distribution
DIN Converter, 5-lead In distribution
ECG TRUNK CABLE, 6-LEAD, AHA, 1.2 M/4 FT In distribution
Invasive Blood Pressure Cable, Edwards LS TruWave, Dual, 3.6 m/12 ft. In distribution
ECG Leadwire set, 5-lead C2-6, grabber, IEC, 130 cm/ 51 in In distribution
ECG Leadwire set, 5-lead, snap, IEC, 74 cm/ 29 in In distribution
ECG TRUNK CABLE, NEONATAL DIN 3-LEAD, IEC, 3.6 M/12 FT In distribution
ECG Leadwire set, 3-lead, snap, AHA, 130 cm/ 51 in In distribution
ECG Leadwire set, 5-lead, grabber, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in In distribution
ECG Leadwire set, 6-lead, grouped, snap, AHA, 130 cm/ 51 in In distribution
ECG Leadwire set, telemetry, 6-lead, grabber, AHA, 27 in In distribution
ECG Leadwire set, 3-lead, snap, IEC, 74 cm/ 29 in In distribution
DIN Converter, 12-lead Kit In distribution
ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in In distribution
ECG Leadwire set, 6-lead, grouped, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in In distribution
ECG Leadwire set, telemetry, 3-lead, snap, AHA, 27 in In distribution
ECG Leadwire set, 5-lead, grouped, snap, AHA, 130 cm/ 51 in In distribution
ECG Leadwire set, 6-lead, grouped, snap, IEC, 74 cm/ 29 in In distribution
ECG Leadwire set, 5-lead, grabber, IEC, 130 cm/ 51 in In distribution
ECG TRUNK CABLE, NEONATAL DIN 3-LEAD, IEC, 1.2 M/4 FT In distribution
ECG TRUNK CABLE, 12-LEAD, IEC, 1.2 M/4 FT In distribution
ECG Leadwire set, 6-lead, grouped, grabber, AHA, 74 cm/ 29 in In distribution
ECG TRUNK CABLE, NEONATAL DIN 3-LEAD, AHA, 3.6 M/12 FT In distribution
ECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/ 29 in In distribution
ECG Leadwire set, 6-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in In distribution
ECG TRUNK CABLE, NEONATAL DIN 3-LEAD, AHA, 1.2 M/4 FT In distribution
ECG Leadwire set, 5-lead C2-6, snap, IEC, 74 cm/ 29 in In distribution
ECG Leadwire set, 6-lead, grouped, grabber, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in In distribution
Invasive Blood Pressure Cable, Edwards LS TruWave, Single, 3.6 m/12 ft. In distribution
ECG Leadwire set, 5-lead V2-6, snap, AHA, 74 cm/ 29 in In distribution
ECG TRUNK CABLE, 3/5-LEAD, AHA, 3.6 M/12 FT In distribution
ECG Leadwire set, 6-lead, grouped, snap, IEC, 130 cm/ 51 in In distribution
Temperature Cable, 400 Series Probes, Dual, 0.5 m/1.7 ft. In distribution
DIN Converter, 3-lead In distribution
Invasive Blood Pressure Cable, Utah/Biotrans, Single, 3.6 m/12 ft. In distribution
ECG Leadwire set, 5-lead V2-6, snap, AHA, 130 cm/ 51 in In distribution
ECG Leadwire set, 3-lead, grabber, IEC, 74 cm/ 29 in In distribution
ECG TRUNK CABLE, 6-LEAD, AHA, 3.6 M/12 FT In distribution
Invasive Blood Pressure Cable, Argon, Single, 3.6 m/12 ft. In distribution
Temperature Cable, 400 Series Probes, Single, 0.5 m/1.7 ft. In distribution
ECG Leadwire set, 5-lead, grouped, snap, AHA, 74 cm/ 29 in In distribution
ECG Leadwire set, 6-lead, grouped, grabber, IEC, 130 cm/ 51 in In distribution
Cardiac Output Cable, 3.6 m/12 ft. In distribution
ECG TRUNK CABLE, 3/5-LEAD, AHA, 6 M/20 FT In distribution
ECG TRUNK CABLE, 3/5-LEAD, AHA, 1.2 M/4 FT In distribution
ECG Leadwire set, 3-lead, snap, AHA, 74 cm/ 29 in In distribution
ECG Leadwire set, telemetry, 3-lead, grabber, AHA, 27 in In distribution
ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 in In distribution
ECG Leadwire set, 5-lead, grouped, grabber, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in In distribution
ECG Leadwire set, 5-lead, grabber, AHA, 130 cm/ 51 in In distribution
ECG Leadwire set, 5-lead, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in In distribution
ECG LEADWIRE SET, 5-LD, GRABBER, AHA, 74 CM/ 29 IN In distribution
ECG Leadwire set, 3-lead, grabber, IEC, 130 cm/ 51 in In distribution
ECG Leadwire set, 5-lead V2-6, grabber, AHA, 130 cm/ 51 in In distribution
ECG Leadwire set, 5-lead C2-6, grabber, IEC, 74 cm/ 29 in In distribution
ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, IEC, 3.6 M/12 FT In distribution
ECG TRUNK CABLE, 3/5-LEAD W/ESU FILTER, AHA, 3.6 M/12 FT In distribution
ECG Leadwire set, 6-lead, grouped, snap, AHA, 74 cm/ 29 in In distribution
ECG Leadwire set, 5-lead, grouped, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in In distribution
ECG Leadwire set, 5-lead, grouped, grabber, IEC, 130 cm/ 51 in In distribution
ECG Leadwire set, 5-lead, grabber, IEC, 74 cm/ 29 in In distribution
ECG Leadwire set, 5-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in In distribution
ECG TRUNK CABLE, 12-LEAD, AHA, 3.6 M/12 FT In distribution
ECG Leadwire set, 5-lead, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in In distribution
ECG TRUNK CABLE, 3/5-LEAD, IEC, 1.2 M/4 FT In distribution
ECG Leadwire set, 5-lead, grouped, snap, In distribution
ECG Leadwire set, telemetry, 6-lead, snap, AHA, 27 in In distribution
ECG Leadwire set, 5-lead, snap, IEC, 130 cm/ 51 in In distribution
ECG TRUNK CABLE, 3/5-LEAD, IEC, 6 M/20 FT In distribution
ECG Leadwire set, 5-lead, grouped, grabber, IEC, 74 cm/ 29 in In distribution
ECG Leadwire set, 6-lead, grouped, grabber, IEC, 74 cm/ 29 in In distribution
ECG TRUNK CABLE, 3/5-LEAD, IEC, 3.6 M/12 FT In distribution
ECG Leadwire set, telemetry, 5-lead, grabber, AHA, 27 in In distribution
ECG TRUNK CABLE, 6-LEAD, IEC, 3.6 M/12 FT In distribution
Invasive Blood Pressure Cable, Argon, Dual, 3.6 m/12 ft. In distribution
ECG Leadwire set, 3-lead, grabber, AHA, 130 cm/ 51 in In distribution
ECG Leadwire set, 5-lead C2-6, snap, IEC, 130 cm/ 51 in In distribution
ECG Leadwire set, 3-lead, snap, IEC, 130 cm/ 51 in In distribution
ECG Leadwire set, 5-lead V2-6, grabber, AHA, 74 cm/ 29 in In distribution
ECG Leadwire set, 5-lead, grouped, snap, IEC, 74 cm/ 29 in In distribution
ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA, 3.6 M/12 FT In distribution
ECG TRUNK CABLE, 12-LEAD, AHA, 1.2 M/4 FT In distribution
Invasive Blood Pressure Cable, Dual Adapter Cable, 30 cm/1 ft. In distribution
Temperature Cable, 400 Series for Disposable Probes, Single, 3.6 m/12 ft In distribution
Invasive Blood Pressure Cable, ICU Medical Transpac-IV, Single, 1.2 m/4 ft. Withdrawn
Invasive Blood Pressure Cable, Argon, Dual, 1.2 m/4 ft. Withdrawn
Cardiac Output Cable, 2.4 m/8 ft. Withdrawn
Invasive Blood Pressure Cable, ICU Medical Transpac-IV, Dual, 1.2 m/4 ft. Withdrawn
Invasive Blood Pressure Cable, Utah/Biotrans, Dual, 1.2 m/4 ft. Withdrawn
Invasive Blood Pressure Cable, Edwards LS TruWave, Single, 1.2 m/4 ft. Withdrawn
Invasive Blood Pressure Cable, Argon, Single, 1.2 m/4 ft. Withdrawn
Invasive Blood Pressure Cable, Utah/Biotrans, Single, 1.2 m/4 ft. Withdrawn
Invasive Blood Pressure Cable, Edwards LS TruWave, Dual, 1.2 m/4 ft. Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Orantech Orantech Inc. 1,344
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FMT Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi 249
Med-Dyne MED-Dyne 244
Cable, Electrode PMT Corp. 219
Kendall Cardinal Health 200, LLC 212
Kendall Cardinal Health 183
C.M.P. Cable C.M.P. Canadian Medical Products Inc. 154
Cable, Electrode Innovative Health, LLC. 133
Medline Medline Industries, Inc. 112
Cable, Electrode Stryker Sustainability Solutions 110
Lightweight Cabrio Cable AD-Tech Medical Instrument Corp. 99

Showing 12 of 473. All products under Cable, Electrode

Recalls Naming This Product

4 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of Cable, Electrode
Recalled by Identified by Initiated FDA class Root cause Reason Quantity Closed
GE Medical Systems, LLC UDI-DI 2019-05-10 Class III Process design ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm. 58,045 units (31,108 US; 26937 OUS) in total 2024-05-24
GE Medical Systems, LLC UDI-DI 2019-05-10 Class III Process design ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm. 58,045 units (31,108 US; 26937 OUS) in total 2024-05-24
GE Medical Systems, LLC UDI-DI 2019-05-10 Class III Process design ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm. 58,045 units (31,108 US; 26937 OUS) in total 2024-05-24
GE Medical Systems, LLC UDI-DI 2019-02-22 Class III Under Investigation by firm The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduct 25% of the defibrillation energy away from the patient. 288 devices (23 US, 265 OUS) 2020-08-19

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