| Primary Device ID | 00850033352184 |
| NIH Device Record Key | 43686a67-2fb7-42d9-856a-fe18b9d2367f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dario Smart Monitor (Cellular)- Blood Pressure Monitoring System |
| Version Model Number | 1268-05 |
| Company DUNS | 116902485 |
| Company Name | DARIOHEALTH CORP. |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850033352184 [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 | 2026-01-13 |
| Device Publish Date | 2026-01-05 |
| 00850033352184 - Dario Smart Monitor (Cellular)- Blood Pressure Monitoring System | 2026-01-13The Dario Smart Monitor (Cellular)- Blood Pressure Monitoring System is intended for use in measuring blood pressure. The device can be used to detect irregular heartbeat. It is intended for adults indoor use only. |
| 00850033352184 - Dario Smart Monitor (Cellular)- Blood Pressure Monitoring System | 2026-01-13 The Dario Smart Monitor (Cellular)- Blood Pressure Monitoring System is intended for use in measuring blood pressure. The device |
| 00850033352061 - Dario Smart Blood Pressure Monitor Gen 2 | 2022-07-05 The Dario blood pressure monitoring system is intended for measuring blood pressure and heart rate in adults with an arm circumf |
| 00850033352092 - Dario Smart Scale | 2022-07-04 The Dario Smart Scale will accurately measure the weight of children and adults over 20 lbs. (9 kg). The maximum weight limit fo |
| 00850033352078 - Dario Blood Pressure Monitoring System (Large cuff) | 2021-11-15 The Dario Blood Pressure Monitoring System is intended to be used to measure the systolic and diastolic blood pressure and pulse |
| 00850033352085 - Dario Blood Pressure Monitoring System (M cuff) | 2021-11-15 The Dario Blood Pressure Monitoring System is intended to be used to measure the systolic and diastolic blood pressure and pulse |
| 00850065006345 - Dario Blood Pressure Monitoring System (M cuff) | 2020-01-31 |
| 00850065006437 - Dario Blood Pressure Monitoring System (Large cuff) | 2020-01-31 |