| Primary Device ID | 00850033352009 |
| NIH Device Record Key | a93b384a-5fcc-4293-b3a2-fcd50ac5f019 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System |
| Version Model Number | 1168-05 |
| Company DUNS | 600039072 |
| Company Name | LABSTYLE INNOVATION LTD |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850033352009 [Primary] |
| GS1 | 00850033352016 [Package] Package: Box [10 Units] In Commercial Distribution |
| 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 | 2021-08-17 |
| Device Publish Date | 2021-08-09 |
| 00850065006741 - Dario® USB-C Blood Glucose Monitoring System- Welcome Kit | 2023-12-29 The Dario USB-C Blood Glucose Monitoring System Welcome Kit is a compact, all-in-one blood glucose meter that is used in conjunc |
| 00850065006758 - Dario® USB-C Blood Glucose Monitoring System - Starter Kit | 2023-12-29 The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a |
| 00850033352023 - Dario Smart Scale (Cellular) - Weight Management System | 2021-10-25 The Dario Smart Scale (Cellular) - Weight Management System is intended for measuring the body weight of adults and children (ag |
| 00850065006222 - Dario 100 Sterile Lancets | 2021-08-18 The disposable Dario 100 Sterile Lancets pack is intended for use with Dario Blood Glucose Monitoring Systems. The orange lancin |
| 00850033352009 - Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System | 2021-08-17The Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System is digital monitors intended for use in measuring blood pressure. The device can be used to detect irregular heartbeat. It is intended for adult indoor use only |
| 00850033352009 - Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System | 2021-08-17 The Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System is digital monitors intended for use in measuring blood pr |
| 00850065006659 - Dario Super Saver MIB-Supplies | 2021-07-23 |
| 00850065006567 - Dario 300 Test Strips Bundle | 2020-09-03 The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in |
| 00850065006574 - Dario 200 Test Strips Bundle | 2020-09-03 The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in |