| Primary Device ID | 20883489002383 |
| NIH Device Record Key | a3d8b995-54fc-41ba-b67f-857be36168f9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ODM |
| Version Model Number | Diathrive+ Blood Glucose Monitoring System |
| Catalog Number | 99GM280DR1 |
| Company DUNS | 658637244 |
| Company Name | BIONIME CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 866-878-7477 |
| customerservice@diathrive.com |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883489002372 [Primary] |
| GS1 | 00883489002389 [Package] Contains: 00883489002372 Package: Box [1 Units] In Commercial Distribution |
| GS1 | 20883489002383 [Package] Contains: 00883489002389 Package: Box [50 Units] In Commercial Distribution |
| NBW | System, Test, Blood Glucose, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-27 |
| Device Publish Date | 2020-01-17 |
| 00883489001542 | iGlucose test strips |
| 00883489001504 | The combination products includes 1 pce of lancing device_GD500(00883489001566), 1 pc of control |
| 20883489002420 | 25 strips - 80883489002415 |
| 00883489002396 | 1 meter - 00883489002396 |
| 20883489002383 | 1 meter - 00883489002372 |