| Primary Device ID | 00883489002686 |
| NIH Device Record Key | c04de41f-7693-44bb-840c-ae62e7c7fab2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iGlucose Touch Blood Glucose Test Strip |
| Version Model Number | iGlucose Touch |
| 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 | false |
| Single Use | false |
| 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 | 844-445-8267 |
| support@iglucose.com | |
| Phone | 844-445-8267 |
| support@iglucose.com | |
| Phone | 844-445-8267 |
| support@iglucose.com | |
| Phone | 844-445-8267 |
| support@iglucose.com | |
| Phone | 844-445-8267 |
| support@iglucose.com | |
| Phone | 844-445-8267 |
| support@iglucose.com | |
| Phone | 844-445-8267 |
| support@iglucose.com | |
| Phone | 844-445-8267 |
| support@iglucose.com | |
| Phone | 844-445-8267 |
| support@iglucose.com | |
| Phone | 844-445-8267 |
| support@iglucose.com | |
| Phone | 844-445-8267 |
| support@iglucose.com |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883489002679 [Primary] |
| GS1 | 00883489002686 [Package] Contains: 00883489002679 Package: paper box [2 Units] In Commercial Distribution |
| GS1 | 10883489002683 [Package] Package: inner carton [20 Units] In Commercial Distribution |
| GS1 | 20883489002680 [Package] Contains: 10883489002683 Package: carton [12 Units] In Commercial Distribution |
| GS1 | 80883489002675 [Unit of Use] |
| 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 | 2025-12-12 |
| Device Publish Date | 2025-12-04 |
| 00883489002662 - iGlucose Touch Blood Glucose Meter | 2025-12-12 |
| 00883489002686 - iGlucose Touch Blood Glucose Test Strip | 2025-12-12 |
| 00883489002686 - iGlucose Touch Blood Glucose Test Strip | 2025-12-12 |
| 00883489002709 - iGlucose Touch Control Solution | 2025-12-12 Level 2*1 bottle |
| 00883489002563 - GE | 2024-10-29 Kitbox |
| 00883489002525 - SMARTMETER | 2024-01-26 kit only has one meter |
| 00883489002501 - SMARTMETER | 2023-12-25 Control Solution-Level 2 |
| 00883489001306 - RIGHTEST | 2023-07-11 single lancing device |
| 00883489001320 - GE | 2023-07-11 GE Lancing device |