| Primary Device ID | 00850065006567 |
| NIH Device Record Key | 6156ff46-1454-4088-b4e0-341afcb89bb1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dario 300 Test Strips Bundle |
| Version Model Number | 1212-05 |
| Company DUNS | 600039072 |
| Company Name | LABSTYLE INNOVATION LTD |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850065006567 [Primary] |
| CGA | Glucose Oxidase, Glucose |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-03 |
| Device Publish Date | 2020-08-26 |
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| 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 | 2021-08-17 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 | 2020-09-03The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. |
| 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 |