| Primary Device ID | 20883489001898 |
| NIH Device Record Key | 136fc5a0-e62e-435d-bb36-3424377f3a32 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RIGHTEST GT333 Blood Glucose Test Strip |
| Version Model Number | 50 PCS |
| 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 | true |
| 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 | 1 909 781 6969 |
| info@bionimeusa.com |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883489001887 [Primary] |
| GS1 | 00883489001894 [Package] Contains: 00883489001887 Package: paper [2 Units] In Commercial Distribution |
| GS1 | 10883489001891 [Package] Contains: 00883489001894 Package: paper [20 Units] In Commercial Distribution |
| GS1 | 20883489001898 [Package] Contains: 10883489001891 Package: paper [12 Units] In Commercial Distribution |
| GS1 | 80883489001883 [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 | 2019-10-16 |
| Device Publish Date | 2019-10-08 |
| 20883489001911 | 100PCS |
| 20883489001898 | 50 PCS |
| 20883489001874 | 25pcs |