APK
- Primary DI
- 06946725538470
- Brand
- APK
- Company
- APK Technology Co.,Ltd.
- Model
- A2610-EZ6
- Device description
- Electrocardiograph Electrode
- Published
- 2025-09-22
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| DRX | Electrode, Electrocardiograph |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DRX | Electrode, Electrocardiograph | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 06946725538470 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 06946725538470 | 06946725538470 | 6946725538470 |
GMDN Terms
| Term | Definition |
|---|
| Electrocardiographic electrode, reusable | A noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, or adhesive tape, and a conductive gel (some are pre-gelled), or using a suction mechanism; alternatively, some types may be designed to be attached to hand-held heart rate meters. Electrocardiography (ECG) is usually performed using a set of electrodes (e.g., 12) connected to appropriate leads and cables. This is a reusable device. |
Regulatory Flags
- DUNS number
- 529691989
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
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| 10860009331812 | EXG Radiolucent Electrode System 3-Lead Posterior Electrode | CB Innovations, LLC | DRX | 2026-03-09 |
| 10860009331898 | EXG Radiolucent Electrode System 4-Lead Electrode | CB Innovations, LLC | DRX | 2026-03-09 |
| 00860009331853 | EXG Radiolucent Electrode 5-Lead Cardiac Rhythm Electrode | CB Innovations, LLC | DRX | 2026-03-05 |
| 30009336010593 | Nissha Medical Technologies | GRAPHIC CONTROLS ACQUISITION CORP | DRX | 2026-02-26 |
| 30009336010609 | Nissha Medical Technologies | GRAPHIC CONTROLS ACQUISITION CORP | DRX | 2026-02-26 |
| 08033315120394 | BIONEN | BIONEN SAS DI BARBARA NENCIONI & C. | DRX | 2026-02-16 |
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| 06946725512722 | APK | APK Technology Co.,Ltd. | DRX | 2026-01-23 |
| 06946725512739 | APK | APK Technology Co.,Ltd. | DRX | 2026-01-23 |
| 06946725512746 | APK | APK Technology Co.,Ltd. | DRX | 2026-01-23 |
| 06946725512753 | APK | APK Technology Co.,Ltd. | DRX | 2026-01-23 |
| 06946725512760 | APK | APK Technology Co.,Ltd. | DRX | 2026-01-23 |
| 06946725512777 | APK | APK Technology Co.,Ltd. | DRX | 2026-01-23 |
| 06946725512784 | APK | APK Technology Co.,Ltd. | DRX | 2026-01-23 |
| 06946725512791 | APK | APK Technology Co.,Ltd. | DRX | 2026-01-23 |
| 06946725512807 | APK | APK Technology Co.,Ltd. | DRX | 2026-01-23 |
| 06946725512814 | APK | APK Technology Co.,Ltd. | DRX | 2026-01-23 |
| 06946725512821 | APK | APK Technology Co.,Ltd. | DRX | 2026-01-23 |
| 00853512006998 | NIKOTRACE | NIKOMED USA | DRX | 2026-01-23 |
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| 06946725512692 | APK | APK Technology Co.,Ltd. | DRX | 2026-01-20 |
| 29005531002764 | Skintact | Leonhard Lang GmbH | DRX | 2026-01-15 |
| 29005531003044 | Skintact | Leonhard Lang GmbH | DRX | 2026-01-14 |
| 04719872981640 | QT ECG | Qt Medical, Inc. | DRX | 2025-12-30 |
| 06946725512364 | APK | APK Technology Co.,Ltd. | DRX | 2025-12-25 |
| 06946725512371 | APK | APK Technology Co.,Ltd. | DRX | 2025-12-25 |
| 06946725512388 | APK | APK Technology Co.,Ltd. | DRX | 2025-12-25 |
| 06946725512395 | APK | APK Technology Co.,Ltd. | DRX | 2025-12-25 |