| Primary Device ID | 00850042929162 |
| NIH Device Record Key | 209c2047-ec67-4cbc-8bce-467152642811 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MIO |
| Version Model Number | I |
| Company DUNS | 117119317 |
| Company Name | Mio Labs 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850042929162 [Primary] |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-11 |
| Device Publish Date | 2023-09-01 |
| 00850042929070 | GBS-2104-G |
| 00850042929049 | Mio Lancing Device |
| 00850042929032 | Mio Single Use Lancets |
| 00850042929025 | Mio Control Solution |
| 00850042929018 | Blood Glucose Test Strip |
| 00850042929001 | Blood Glucose Meter |
| 00850042929148 | Mio Blood Glucose Test Strip |
| 00850042929131 | Mio Blood Glucose Meter |
| 10850042929169 | Mio Single Use Lancets |
| 00850042929179 | Mio Lancing Device |
| 00850042929162 | Mio Single Use Lancets |
| 00850042929155 | Mio Control Solution |
| 00850042929186 | MIO Blood Glucose Monitoring System |