| Primary Device ID | 00883489001542 |
| NIH Device Record Key | 85cb07ac-4b70-4d4b-be50-ec5fea6656d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ODM |
| Version Model Number | iGlucose test strips |
| Catalog Number | 99GS291I51 |
| Company DUNS | 658637244 |
| Company Name | BIONIME CORPORATION |
| Device Count | 25 |
| DM Exempt | false |
| 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 | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Phone | 1-844-445-8267 |
| support@iglucose.com |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883489001542 [Primary] |
| GS1 | 00883489001559 [Package] Package: box [2 Units] In Commercial Distribution |
| GS1 | 10883489001556 [Package] Contains: 00883489001559 Package: case [20 Units] In Commercial Distribution |
| GS1 | 20883489001553 [Package] Contains: 10883489001556 Package: carton [12 Units] In Commercial Distribution |
| GS1 | 80883489001548 [Unit of Use] |
| NBW | System, Test, Blood Glucose, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-07-19 |
| 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 |