Electrode, Electrocardiograph
ECG Electrodes, Neonatal, Radiolucent, pre-wired with DIN 3-lead set, AHA
33manufacturers in China registered for this device type
17catalogue numbers in this listing
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 | Carefusion Finland 320 Oy |
|---|---|
| FDA product code | DRX |
| Device type | Electrode, Electrocardiograph |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2360 |
| Premarket notification | Exempt |
| Record published | 2016-09-22 |
| Record revised | 2024-05-22 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 14 to 104 °F |
| Packaging | Case of 10, case of 200, pack of 10, case of 5, case of 120 |
| Distribution end date | 2022-03-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2009110-050R | 50 | Withdrawn | |
| 2009101-404 | 3 | Withdrawn | |
| 2009109-050 | 50 | Withdrawn | |
| 2009101-003 | 100 | Withdrawn | |
| 2009101-103P | 140 | Withdrawn | |
| 2009101-404 | 3 | Withdrawn | |
| 2009101-403 | 3 | Withdrawn | |
| 2009101-210 | 100 | Withdrawn | |
| 2009110-050 | 50 | Withdrawn | |
| 2009110-050W | 50 | Withdrawn | |
| 2009109-005 | 3 | Withdrawn | |
| 2009111-050 | 50 | Withdrawn | |
| 2009110-150 | 50 | Withdrawn | |
| 2009111-150 | 50 | Withdrawn | |
| 2009110-005 | 5 | Withdrawn | |
| 2009110-003 | 3 | Withdrawn | |
| 2009101-003P | 100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| APK | APK Technology Co., Ltd. | 113 |
| Electrode, Electrocardiograph | Fiab SPA | 109 |
| 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 |
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.