| Primary Device ID | 04059358001555 |
| NIH Device Record Key | 55a508ca-d784-4aa7-aa70-dc5b99ff009f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ERGOMETER EBIKE III COMFORT |
| Version Model Number | 2017911-305 |
| Company DUNS | 314403192 |
| Company Name | ergoline GmbH |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04059358001555 [Primary] |
| ISD | Exerciser, Measuring |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-08-02 |
| 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 |