| Primary Device ID | 04035479062279 |
| NIH Device Record Key | 9acf50f3-c9ce-4bcb-aeb5-8b15b6abec58 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PK Electrode Clip |
| Version Model Number | 340293 |
| Catalog Number | 340293 |
| Company DUNS | 315620229 |
| Company Name | BIOTRONIK SE & Co. KG |
| Device Count | 4 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035479062279 [Primary] |
| GS1 | 04035479147129 [Unit of Use] |
| KRG | Programmer, pacemaker |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-22 |
| Device Publish Date | 2014-08-25 |
| 04035479184575 - BIOTRONIK | 2024-02-28 |
| 04035479116644 - Selectra | 2024-01-25 |
| 04035479184285 - NEO | 2023-12-25 |
| 04035479184292 - PSW | 2023-12-25 |
| 04035479185510 - Renamic Neo NEOexpress | 2023-12-25 |
| 04035479183264 - Home Monitoring Service Center | 2023-10-23 |
| 04035479100650 - S 60-C | 2023-10-09 |
| 04035479011864 - S 75-A | 2023-10-06 |