Vermed
SET OF 3 PRE-Wired Pediatric Electrodes
33manufacturers in China registered for this device type
45catalogue 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 | Graphic Controls Acquisition Corporation |
|---|---|
| FDA product code | DRX |
| Device type | Electrode, Electrocardiograph |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2360 |
| 510(k) | K101685 |
| Record published | 2017-02-17 |
| Record revised | 2019-06-04 (version 4) |
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, manufacturing date |
| Packaging | Pack of 1000, pack of 12, pack of 100, pack of 7200, pack of 1200, pack of 120 |
| Distribution end date | 2023-04-14 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| A10091-4 | 10 | In distribution | |
| Offset Electrode | 60 | In distribution | |
| A10091-3 | 3 | In distribution | |
| V8955 | 5 | In distribution | |
| Offset Electrode | 60 | In distribution | |
| A10091-5 | 5 | In distribution | |
| Offset Electrode | 60 | In distribution | |
| A10091-30 | 30 | In distribution | |
| A10202-10 | 10 | In distribution | |
| A10091-5 | 5 | In distribution | |
| A10091-10 | 10 | In distribution | |
| A10202 | 100 | In distribution | |
| A10091-30 | 30 | In distribution | |
| Offset Electrode | 5 | In distribution | |
| Offset Electrode | 5 | In distribution | |
| Tab & Snap Electrode | 5 | In distribution | |
| Offset Electrode | 60 | In distribution | |
| Offset Electrode | 5 | In distribution | |
| V8850 | 50 | In distribution | |
| V8830 | 30 | In distribution | |
| Offset Electrode | 5 | In distribution | |
| P10072-7NB | 7 | In distribution | |
| P10072-5NB | 5 | In distribution | |
| A10091-4 | 4 | In distribution | |
| V8855 | 5 | In distribution | |
| A10091-10 | 10 | In distribution | |
| P10097-5NB | 5 | In distribution | |
| Offset Electrode | 100 | In distribution | |
| A10091-3 | 3 | In distribution | |
| V8950 | 50 | In distribution | |
| V88100 | 100 | Withdrawn | |
| IP-Set M3 RT Adult-US | Withdrawn | ||
| IP-Set 5V RT Adult-US | Withdrawn | ||
| V8833 | 3 | Withdrawn | |
| IP-Set N3-Pediatric-US | Withdrawn | ||
| IP-Set 12 RT Adult-US | Withdrawn | ||
| V8930 | 30 | Withdrawn | |
| IP-Set 5V RT Adult-US | Withdrawn | ||
| IP-Set 12 RT Adult-US | Withdrawn | ||
| IP-Set 6V RT ADULT-US | Withdrawn | ||
| IP-Set 6V RT ADULT-US | Withdrawn | ||
| IP-Set M5 RT Adult-US | Withdrawn | ||
| IP-Set M3 RT Adult-US | Withdrawn | ||
| IP-Set M5 RT Adult-US | Withdrawn | ||
| IP-Set N3-Pediatric-US | 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 |
| Red Dot™ | 3M Company | 44 |
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.