| Primary Device ID | 04711200720617 |
| NIH Device Record Key | ce013be7-5175-4e55-9eff-4e30e57b1850 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GlucoLeader Enhance Blood Glucose Monitoring System |
| Version Model Number | 3K-01-140036 |
| Catalog Number | 3K-01-140036 |
| 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 |