| Primary Device ID | 04059358003740 |
| NIH Device Record Key | 58f96824-39f0-4fa9-b562-000b6cd64f11 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ergoselect 5 |
| Version Model Number | 191004 |
| Company DUNS | 314403192 |
| Company Name | ergoline GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 04059358003740 [Primary] |
| ISD | Exerciser, Measuring |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-18 |
| Device Publish Date | 2023-05-10 |
| 04059358002224 - optibike basic | 2023-05-22 |
| 04059358001746 - ers2 1CH Telemetry Transmitter | 2023-05-18 |
| 04059358001753 - ers2 ECG Receiver | 2023-05-18 |
| 04059358001760 - ers2 1CH ECG Adapter | 2023-05-18 |
| 04059358001777 - ers2 1CH ECG Transmitter Set (Adapter) | 2023-05-18 |
| 04059358001821 - ergoselect 1 | 2023-05-18 |
| 04059358001838 - ers2 Basic Software | 2023-05-18 |
| 04059358002095 - ers2 1CH ECG Adapter US Set 5 pcs. | 2023-05-18 |