| Primary Device ID | 04260441450574 |
| NIH Device Record Key | d321576a-3362-46c1-abb1-f8c6acbc92ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aluminium carrying case |
| Version Model Number | 08ACC01 |
| Company DUNS | 415868731 |
| Company Name | CardioTek B.V. |
| Device Count | 1 |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260441450574 [Primary] |
| DQK | Computer, Diagnostic, Programmable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-07 |
| Device Publish Date | 2020-01-30 |
| 04260441455326 - EP-TRACER | 2021-02-11 EP-TRACER 70 included in the stationary system setup. The EP-TRACER system is a computerized electrophysiology measurement syst |
| 04260441455425 - EP-TRACER | 2020-09-22 EP-TRACER 70 included in the portable system setup. The EP-TRACER system is a computerized electrophysiology measurement system |
| 04260441450482 - Adapter cables unipolar/ bipolar (set of 10) | 2020-02-25 |
| 04260441450574 - Aluminium carrying case | 2020-02-07 |
| 04260441450574 - Aluminium carrying case | 2020-02-07 |
| 04260441455418 - EP-TRACER | 2020-01-28 EP-TRACER 38 included in the portable system setup. The EP-TRACER system is a computerized electrophysiology measurement system |