Claravue
Set of 10 Patient Monitoring ECG Pre Wired Electrodes Radio Translucent for Adult Patients
33manufacturers in China registered for this device type
7catalogue 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 | Nissha Medical Technologies Limited, United Kingdom |
|---|---|
| FDA product code | DRX |
| Device type | Electrode, Electrocardiograph |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2360 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K101685 |
| Record published | 2021-07-13 |
| Record revised | 2023-04-06 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 59 to 95 °F |
| Packaging | Box of 30, case of 360, box of 40, case of 480, box of 25, case of 300 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CLARAVUE PM M5 RT US | In distribution | |
| 50604-US | In distribution | |
| 50603-US | In distribution | |
| 50600-US | In distribution | |
| CLARAVUE PM D12 RT US | In distribution | |
| CLARAVUE PM NEONAT/PEDIATRIC 3 RT | In distribution | |
| CLARAVUE PM 12 RT CARDIO | In distribution |
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
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | 510(k) number | 2022-03-15 | Class II | Device Design | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an applicatio | 40 units | 2024-07-12 |
| Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | 510(k) number | 2022-03-15 | Class II | Device Design | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an applicatio | 560 units | 2024-07-12 |
| Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | 510(k) number | 2022-03-15 | Class II | Device Design | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an applicatio | 19470 units | 2024-07-12 |
| Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | 510(k) number | 2022-03-15 | Class II | Device Design | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an applicatio | 8265 units | 2024-07-12 |
| Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | 510(k) number | 2022-03-15 | Class II | Device Design | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an applicatio | 2024-07-12 | |
| Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | 510(k) number | 2022-03-15 | Class II | Device Design | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an applicatio | 2024-07-12 |
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.