Cable, Electrode
Kendall DL Disposable Philips Direct Connect 5 Lead Telemetry System
47manufacturers in China registered for this device type
9catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Guangdong (31), Jiangsu (4), Shandong (3). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen Caremed Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| ABA Medical Technology Co Ltd | Guang Dong | Guangdong | Contract manufacturer | 6 |
| Tasco Medical Industries Co., Ltd. | Bao An District, Shenzhen | Guangdong | Contract manufacturer | 6 |
| Beijing Rongrui Century Science Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 4 |
| Dongguan Ruibaolian Medical Science & Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dongguan Kepler Special Cabling Company Limited | Dongguan | Guangdong | Contract manufacturer | 3 |
Showing 12 of 47. All 47 manufacturers in China registered for Cable, Electrode
Record
| Listed by | Sterilmed, Inc., United States |
|---|---|
| FDA product code | IKD |
| Device type | Cable, Electrode |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1175 |
| Establishment | Reprocessor, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-22 |
| Record revised | 2025-07-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Carton of 10, carton of 5 |
| Distribution end date | 2025-06-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| COV33112 | Withdrawn | |
| COV33110 | Withdrawn | |
| COV33114 | Withdrawn | |
| COV33111 | Withdrawn | |
| COV33135 | Withdrawn | |
| COV33105 | Withdrawn | |
| COV33103 | Withdrawn | |
| COV33136 | Withdrawn | |
| COV33145 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Orantech | Orantech Inc. | 1,344 |
| APK | APK Technology Co., Ltd. | 1,081 |
| FMT | Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi | 249 |
| Med-Dyne | MED-Dyne | 244 |
| Cable, Electrode | PMT Corp. | 219 |
| Kendall | Cardinal Health 200, LLC | 212 |
| Kendall | Cardinal Health | 183 |
| C.M.P. Cable | C.M.P. Canadian Medical Products Inc. | 154 |
| Cable, Electrode | Innovative Health, LLC. | 133 |
| Medline | Medline Industries, Inc. | 112 |
| Cable, Electrode | Stryker Sustainability Solutions | 110 |
| Cable, Electrode | GE Healthcare Finland OY | 103 |
Showing 12 of 473. All products under Cable, Electrode
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2008-08-08 | Not classified | Packaging process control | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on o | 49 | 2011-04-26 |
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.