| Primary Device ID | 00860011532828 |
| NIH Device Record Key | 54f70f44-3bba-49d8-b098-842db8c5e10c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DaliaSense |
| Version Model Number | 1 |
| Company DUNS | 119180228 |
| Company Name | Stethoai LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860011532828 [Primary] |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-23 |
| Device Publish Date | 2024-04-15 |
| 00860011532828 - DaliaSense | 2024-04-23A Bluetooth blood pressure monitor compatible with the DaliaHealth platform, measuring heart rate, diastolic and systolic blood pressure, and an AI analysis for irregular heartbeats. |
| 00860011532828 - DaliaSense | 2024-04-23 A Bluetooth blood pressure monitor compatible with the DaliaHealth platform, measuring heart rate, diastolic and systolic blood |
| 00860011532804 - StethoAI Digital Stethoscope | 2024-01-26 A high-quality digital stethoscope that connects directly to the 3.5mm jack of your computer or your mobile phone. |