| Primary Device ID | 00385930000000 |
| NIH Device Record Key | 4e445a20-d591-42bf-940e-87d99eea2648 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UltraTRAK TM Complete Blood Glucose Monitoring System |
| Version Model Number | TD-4231 |
| Company DUNS | 808107788 |
| Company Name | VERTEX DIAGNOSTICS LLC |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 | 00385930000000 [Primary] |
| 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 | 2020-01-31 |
| Device Publish Date | 2020-01-23 |
| 00385930000000 - UltraTRAK TM Complete Blood Glucose Monitoring System | 2020-01-31 |
| 00385930000000 - UltraTRAK TM Complete Blood Glucose Monitoring System | 2020-01-31 |
| 00385930000017 - UltraTRAK Complete 50 Test Strips | 2020-01-31 |
| 00385930011013 - UltraTRAK TM 50 Test Strips | 2020-01-31 |
| 00385930011020 - Ultra TRAK PRO Blood Glucose Monitoring System | 2020-01-31 |
| 00385930011082 - UltraTRAK PRO Blood Glucose Monitoring System | 2020-01-31 |
| 00385930011099 - UltraTrak TM ULTIMATE Blood Glucose Monitoring System | 2020-01-31 |
| 00385930011112 - Ultra TRAK TM ULTIMATE TEST STRIP (50 Test Strips) | 2020-01-31 |