Electrode, Electrocardiograph
Disposable ECG RADIOLUCENT electrodes with liquid gel, 32x44mm dimensions, Silver/Silver Chloride (SSC) sensor and carbon snap. F9047RM model is suitable both for rest and stress or Holter…
Disposable ECG RADIOLUCENT electrodes with liquid gel, 32x44mm dimensions, Silver/Silver Chloride (SSC) sensor and carbon snap. F9047RM model is suitable both for rest and stress or Holter ECG recording, with a direct application onto the skin.The SSC sensor permits a reliable and stable recording. The peculiar feature of the electrode is the carbon snap that makes it radiolucent. Neither of the components contains any ferromagnetic materials, therefore the electrodes are fully compatible with MRI applications. The electrodes are MRI tested for use up to 3 T electro-magnetic field. The use of the electrodes do not affect the safety and functioning of Magnetic Resonance Imaging Systems. The external layer in waterproof medical grade PE foam protects the skin beneath the electrode from air and contaminating fluids
Who Else Makes It
Concentrated in Guangdong (12), Jiangsu (6), Zhejiang (6). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| China Qingdao Bright Medical Manufacturing Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 8 |
| Linxens Healthcare (Tianjin) Co., Ltd. | Jinnan District | Tianjin | Contract manufacturer | 7 |
| Dongguan Ruibaolian Medical Science & Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Shanghai Yuechen Medical Supply Co..ltd. | Shanghai | Shanghai | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
Showing 12 of 33. All 33 manufacturers in China registered for Electrode, Electrocardiograph
Record
| Listed by | Fiab SPA, Italy |
|---|---|
| FDA product code | DRX |
| Device type | Electrode, Electrocardiograph |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2360 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-06-12 |
| Record revised | 2020-09-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 0 to 50 °C; Storage environment atmospheric pressure 20 to 80 % RH |
| Packaging | Pack of 10, pack of 50, pack of 5, pack of 24, pack of 20, pack of 6 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| F9016SSC | 6 | In distribution | |
| F9047/4FL | 50 | In distribution | |
| F9070P | 30 | In distribution | |
| F9002SSC | 6 | In distribution | |
| F9024SSC2W | 2 | In distribution | |
| F9011P | 4 | In distribution | |
| F9053/41 | 150 | In distribution | |
| F9015SSC/RU | 6 | In distribution | |
| F9008SSC/RU | 6 | In distribution | |
| F9007 | 6 | In distribution | |
| F9070RM | 50 | In distribution | |
| F9058N/60 | 3 | In distribution | |
| F9053RM | 30 | In distribution | |
| F9007PL | 6 | In distribution | |
| F9058PRM | 3 | In distribution | |
| F9024SSCGI | 4 | In distribution | |
| F9027 | 6 | In distribution | |
| F9069RM | 50 | In distribution | |
| F9009SSC/RU | 6 | In distribution | |
| F9029Q | 6 | In distribution | |
| F9009ULTRA | 6 | In distribution | |
| F9009SSC | 6 | In distribution | |
| F2080 | 50 | In distribution | |
| F9060 | 50 | In distribution | |
| F9029/60 | 6 | In distribution | |
| F9023SSC | 4 | In distribution | |
| F9002NI | 6 | In distribution | |
| F9024SSCVE | 4 | In distribution | |
| F9003SSC | 6 | In distribution | |
| F2060P | 50 | In distribution | |
| F9015SSC | 6 | In distribution | |
| F9053PR/10 | 30 | In distribution | |
| F9023PLUS | 3 | In distribution | |
| F9008SSC | 6 | In distribution | |
| F9053PR | 30 | In distribution | |
| F2080P | 50 | In distribution | |
| F9060X/AUS | 50 | In distribution | |
| F9053NRM | 30 | In distribution | |
| F9069PRM | 50 | In distribution | |
| F9024SSC | 4 | In distribution | |
| F9053 | 30 | In distribution | |
| F9058P/120 | 3 | In distribution | |
| F9024ULTRA | 4 | In distribution | |
| F9053N/10 | 30 | In distribution | |
| F9028 | 6 | In distribution | |
| F9011PG | 4 | In distribution | |
| F9053PRRM/80 | 30 | In distribution | |
| F9047RM | 50 | In distribution | |
| F9057N | 3 | In distribution | |
| F9024NI | 4 | In distribution | |
| F9057NRM | 3 | In distribution | |
| F9008PLUS | 6 | In distribution | |
| F9008NI | 6 | In distribution | |
| F9009PLUS | 6 | In distribution | |
| F9029 | 6 | In distribution | |
| F9067 | 50 | In distribution | |
| F9057PR | 3 | In distribution | |
| F9049 | 50 | In distribution | |
| F9024PLUS | 4 | In distribution | |
| F9070 | 50 | In distribution | |
| F9016SSC/RU | 6 | In distribution | |
| F9058NRM | 3 | In distribution | |
| F9003NI | 6 | In distribution | |
| F9058PR | 3 | In distribution | |
| F9016ULTRA | 6 | In distribution | |
| F9049/100 | 100 | In distribution | |
| F2017/4FL | 50 | In distribution | |
| F2017H | 30 | In distribution | |
| F9046 | 100 | In distribution | |
| F9058N | 3 | In distribution | |
| F9058/90NRM | 3 | In distribution | |
| F9060/5 | 5 | In distribution | |
| F9010SSC-6 | 6 | In distribution | |
| F9058PRRM | 3 | In distribution | |
| F9058P/60 | 3 | In distribution | |
| F9053N | 30 | In distribution | |
| F9057PRRM | 3 | In distribution | |
| F9057P | 3 | In distribution | |
| F9053N/55 | 30 | In distribution | |
| F9053PRRM | 30 | In distribution | |
| F9047 | 50 | In distribution | |
| F9016PLUS | 6 | In distribution | |
| F9060P | 50 | In distribution | |
| F9010SSC | 4 | In distribution | |
| F9069NRM | 50 | In distribution | |
| F9016NI | 6 | In distribution | |
| F9010PSSC | 4 | In distribution | |
| F9058P | 3 | In distribution | |
| F9053/10 | 30 | In distribution | |
| F9057PRM | 3 | In distribution | |
| F9024CSSC | 4 | In distribution | |
| F9023NI | 4 | In distribution | |
| F2017 | 50 | In distribution | |
| F9024ONI | 4 | In distribution | |
| F9053P/55 | 30 | In distribution | |
| F9089P/100 | 100 | In distribution | |
| F9024OSSC | 4 | In distribution | |
| F9048 | 50 | In distribution | |
| F9079P/100 | 100 | In distribution | |
| F9024SSCRO | 4 | In distribution | |
| F9024SSCNE | 4 | In distribution | |
| F9053RM/80 | 30 | In distribution | |
| F9089/100 | 100 | In distribution | |
| F9046RM | 100 | In distribution | |
| F9053P | 30 | In distribution | |
| F2017P | 50 | In distribution | |
| F9047/4F | 50 | In distribution | |
| F9009NI | 6 | In distribution | |
| F9007P | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| APK | APK Technology Co., Ltd. | 113 |
| Swaromed | Tyrolmed GmbH | 93 |
| MediMax Tech | Medimax Tech Inc. | 91 |
| Kendall | Cardinal Health | 91 |
| Medline | Medline Industries, Inc. | 78 |
| AMC | LifeSync Corporation | 74 |
| Kendall | Cardinal Health 200, LLC | 73 |
| Ambu WhiteSensor | Medico Electrodes International Ltd | 51 |
| Z-Brand™ | Graphic Controls Acquisition Corporation | 48 |
| S&W | Leonhard Lang Gmbh | 47 |
| Vermed | Graphic Controls Acquisition Corporation | 45 |
| Red Dot™ | 3M Company | 44 |
Showing 12 of 337. All products under Electrode, Electrocardiograph
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.