HeartStart
Additional 7-Wire Lead Set for 12 Lead (IEC)
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | Philips Medical Systems Hsg |
|---|---|
| FDA product code | DRO |
| Device type | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5550 |
| Record published | 2017-03-27 |
| Record revised | 2024-09-16 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Storage environment temperature -20 to 70 °C; Storage environment temperature -4 to 158 °F |
| Distribution end date | 2022-02-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7-Wire Lead Set for 12-lead use IEC | Withdrawn | |
| 3-Wire Lead Set and Plug Snap IEC | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| M Series Biphasic | Zoll Medical Corporation | 97 |
| Defibrillation Electrodes | TZ Medical, Inc. | 31 |
| Medi-Trace Cadence | Cardinal Health | 17 |
| Kendall | Cardinal Health | 5 |
| R Series | Zoll Medical Corporation | 5 |
| Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | Philips Medical Systems Hsg | 2 |
| PAD 3020-XLT | TZ Medical, Inc. | 1 |
| Pedi-Padz | Zoll Medical Corporation | 1 |
| PAD 1115Z | TZ Medical, Inc. | 1 |
| Pad 101NHK | TZ Medical, Inc. | 1 |
| PAD 1114 | TZ Medical, Inc. | 1 |
| PAD 3020-HP | TZ Medical, Inc. | 1 |
Showing 12 of 36. All products under Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
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.