| Primary Device ID | 04711200722246 |
| NIH Device Record Key | 8337a70e-aca2-4f58-a201-4b1fa2214703 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GlucoLeader Enhance Blood Glucose Monitoring System(BR/IQ) |
| Version Model Number | 3K-01-140108 |
| Catalog Number | 3K-01-140108 |
| Company DUNS | 658644174 |
| Company Name | HMD BIOMEDICAL INC. |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| 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 |
| Storage Environment Temperature | Between 8 Degrees Celsius and 44 Degrees Celsius |
| Storage Environment Temperature | Between 46.6 Degrees Fahrenheit and 111.2 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 8 Degrees Celsius and 44 Degrees Celsius |
| Storage Environment Temperature | Between 46.6 Degrees Fahrenheit and 111.2 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 8 Degrees Celsius and 44 Degrees Celsius |
| Storage Environment Temperature | Between 46.6 Degrees Fahrenheit and 111.2 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |