| Primary Device ID | 00850033352023 |
| NIH Device Record Key | b714da12-7400-41ad-b746-6f6df03d85ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dario Smart Scale (Cellular) - Weight Management System |
| Version Model Number | 1169-05 |
| Company DUNS | 600039072 |
| Company Name | LABSTYLE INNOVATION LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 00850033352023 [Primary] |
| FRI | Scale, Stand-On, Patient |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-25 |
| Device Publish Date | 2021-10-17 |
| 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 | 2021-10-25The Dario Smart Scale (Cellular) - Weight Management System is intended for measuring the body weight of adults and children (aged 10-17 years old). It is intended for indoor use only. |
| 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 | 2021-08-17 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 |