Pacel™
Flow Directed Pacing Catheter
3manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen Launch Electrical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
Record
| Listed by | St. Jude Medical Cardiovascular Division |
|---|---|
| FDA product code | LDF |
| Device type | Electrode, Pacemaker, Temporary |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3680 |
| Record published | 2016-01-28 |
| Record revised | 2023-11-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store in a cool, dark, dry place. Keep dry and keep away from sunlight. |
| Packaging | Pack of 5 |
| Sizes | Catheter gauge 4 to 7 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 401761 | Catheter Gauge 5 Fr | In distribution |
| 401764 | Catheter Gauge 5 Fr | In distribution |
| 401768 | Catheter Gauge 7 Fr | In distribution |
| 401765 | Catheter Gauge 4 Fr | In distribution |
| 401772 | Catheter Gauge 7 Fr | In distribution |
| 401763 | Catheter Gauge 5 Fr | In distribution |
| 401774 | Catheter Gauge 6 Fr | In distribution |
| 401766 | Catheter Gauge 5 Fr | In distribution |
| 401776 | Catheter Gauge 6 Fr | In distribution |
| 401775 | Catheter Gauge 5 Fr | In distribution |
| 401770 | Catheter Gauge 5 Fr | In distribution |
| 401769 | Catheter Gauge 4 Fr | In distribution |
| 401771 | Catheter Gauge 6 Fr | In distribution |
| 401762 | Catheter Gauge 5 Fr | In distribution |
| 401773 | Catheter Gauge 5 Fr | In distribution |
| 401767 | Catheter Gauge 6 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E Medical Corporation | 109 |
| Myo/Wire | A & E Medical Corporation | 76 |
| TB | Oscor Inc. | 40 |
| Temporary Myocardial Heartwire | Oscor Inc. | 27 |
| Ethicon | Ethicon, Inc. | 15 |
| Flexon | Covidien LP | 13 |
| Electrode, Pacemaker, Temporary | Medtronic, Inc. | 12 |
| Nbih™ Temporary Pacing Electrode Catheter | C.R. Bard, Inc. | 11 |
| Electrode, Pacemaker, Temporary | C.R. Bard, Inc. | 10 |
| Streamline™ | Medtronic, Inc. | 10 |
| Steelex | B Braun Surgical SA | 9 |
| Helios | Oscor Inc. | 8 |
Showing 12 of 31. All products under Electrode, Pacemaker, Temporary
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.