Red Dot™
3M™ Red Dot™ Neonatal, Pre-Wired, Radiolucent Monitoring Electrode with Clear Tape 2269T, 3/BG 10BG/BX 10BX/CASE
33manufacturers in China registered for this device type
44catalogue numbers in this listing
5510(k) clearances naming this product code
7recalls on this code
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 | 3M Company, United States |
|---|---|
| FDA product code | DRX |
| Device type | Electrode, Electrocardiograph |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2360 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2024-08-16 (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 |
| Packaging | Box of 20, box of 200, box of 100, box of 40, box of 4, carton of 10 |
| Distribution end date | 2024-08-15 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2270-5 | 5 | In distribution | |
| 2360 | 100 | In distribution | |
| 9641 | 50 | In distribution | |
| 2289PA | 5 | In distribution | |
| 2237 | 50 | In distribution | |
| 2660-3 | 3 | In distribution | |
| 2330 | 100 | In distribution | |
| 2570 | 50 | In distribution | |
| 9650 | 10 | In distribution | |
| 2259-3 | 3 | In distribution | |
| 9642 | 50 | In distribution | |
| 2560 | 50 | In distribution | |
| 2570-5 | 5 | In distribution | |
| 2238-5 | 5 | In distribution | |
| 2230 | 50 | In distribution | |
| 2271-50 | 50 | In distribution | |
| 2248-50 | 50 | In distribution | |
| 2271-5 | 5 | In distribution | |
| 2236 | In distribution | ||
| 9640 | 50 | In distribution | |
| 2249-50 | 50 | In distribution | |
| 2570-3 | 3 | In distribution | |
| 2259-50 | 50 | In distribution | |
| 2270-50 | 50 | In distribution | |
| 2255-50 | 50 | In distribution | |
| 2280 | 300 | In distribution | |
| 2256-50 | 50 | In distribution | |
| 2660-5 | 5 | In distribution | |
| 2282 | 300 | In distribution | |
| 2245-50 | 50 | In distribution | |
| 2670-5 | 5 | In distribution | |
| 2269T | 3 | In distribution | |
| 2670-3 | 3 | In distribution | |
| 2284 | 300 | In distribution | |
| 2238 | 50 | In distribution | |
| 2235 | 50 | In distribution | |
| 2289PAL | 5 | In distribution | |
| 2268-3 | 3 | In distribution | |
| 2283 | 300 | In distribution | |
| 2231 | 50 | In distribution | |
| 2282L | 300 | In distribution | |
| 2289T | 3 | In distribution | |
| 2239 | 50 | In distribution | |
| 2236 | 36 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K974445 | 1998-07-26 |
| K970796 | 1997-04-09 |
| K902080 | 1990-07-18 |
| K896155 | 1989-12-13 |
| K821438 | 1982-05-25 |
Recalls
6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-10-06 | Class II | Process control | Potential for breakage of the ECG electrode carbon stud from the eyelet. | 2,081,000 electrodes | 2024-01-17 |
| 2020-09-15 | Class II | Process control | Corrosion could cause performance failures in the product. | 720,000 | 2022-02-01 |
| 2020-09-15 | Class II | Process control | Corrosion could cause performance failures in the product. | 10,145,050 units | 2022-02-01 |
| 2020-09-15 | Class II | Process control | Corrosion could cause performance failures in the product. | 1,572,000 units | 2022-02-01 |
| 2020-09-15 | Class II | Process control | Corrosion could cause performance failures in the product. | 287,200 units | 2022-02-01 |
| 2020-09-15 | Class II | Process control | Corrosion could cause performance failures in the product. | 156,600 units | 2022-02-01 |
| 2010-07-27 | Not classified | Process control | The sensing element of the 3M Red Dot Monitoring Electrode, Catalog # 2560 and Novaplus Universal Monitoring Electrode #V2560 may have corrosion. In an emergency situation where defibrillation is necessary and electrodes are already in use | 11,063 cases (20 pouches/case, 50 electrodes/pouch) | 2012-04-19 |
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.