| Primary Device ID | 06430035220328 |
| NIH Device Record Key | 28e9aace-4413-4c38-8017-10103fb45d58 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bittium Faros 180 waterproof |
| Version Model Number | Faros 180 |
| Company DUNS | 369960000 |
| Company Name | Bittium Biosignals Oy |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06430035220328 [Primary] |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-27 |
| Device Publish Date | 2021-12-17 |
| 06430035220328 - Bittium Faros 180 waterproof | 2021-12-27Device for 1-channel ECG and motion measurement, monitoring and data collection |
| 06430035220328 - Bittium Faros 180 waterproof | 2021-12-27 Device for 1-channel ECG and motion measurement, monitoring and data collection |
| 06430035220519 - Bittium OmegaSnap | 2021-12-27 1-CH ECG Electrode |
| 06430035220588 - Bittium OmegaSnap | 2021-12-27 Bittium OmegaSnap 1-CH Adapter |
| 06430035220670 - Bittium OmegaSnap | 2021-12-27 2-CH ECG Electrode |
| 06430035220687 - Bittium OmegaSnap | 2021-12-27 3-CH ECG Electrode |
| 06430035220694 - Bittium OmegaSnap | 2021-12-27 Bittium MiniSnap Sensitive 1-CH ECG Electrode |
| 06430035220700 - Bittium OmegaSnap | 2021-12-27 Bittium OmegaSnap Multi-CH Adapter |