| Primary Device ID | 04059358001678 |
| NIH Device Record Key | d9d0c35b-1ab1-449c-a6a5-4b6c0d298d6b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Couch Ergometer ergoselect 12, Bluetooth |
| Version Model Number | 192001.Y |
| 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 | 04059358001678 [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 | 2018-04-30 |
| Device Publish Date | 2018-03-28 |
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