| Primary Device ID | 00850001462419 |
| NIH Device Record Key | 04d84361-934e-4c27-8ad5-bab1225ee6e7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GOJJI KETONE CONTROL SOLUTION-L1 |
| Version Model Number | v1 |
| Company DUNS | 006572586 |
| Company Name | GOJJI, 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850001462419 [Primary] |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-28 |
| Device Publish Date | 2020-04-20 |
| 00850001002011 - GOJJI BLOOD PRESSURE WELCOME KIT | 2020-12-31 |
| 00850001462112 - GOJJI MULTIFUNCTION (GLUC-KETONE) METER | 2020-04-28 |
| 00850001462129 - GOJJI MULTIFUNCTION (GLUC-KETONE) METER | 2020-04-28 |
| 00850001462402 - GOJJI GLUCOSE CONTROL SOLN-NORMAL | 2020-04-28 |
| 00850001462419 - GOJJI KETONE CONTROL SOLUTION-L1 | 2020-04-28 |
| 00850001462419 - GOJJI KETONE CONTROL SOLUTION-L1 | 2020-04-28 |
| 00850001462006 - GOJJI MULTIFUNCTION (GLUC-KETONE) KT | 2020-04-16 |
| 00850001462037 - GOJJI MULTIFUNCTION (GLUC-KETONE) KT | 2020-04-16 |
| 00850001462105 - GOJJI LANCING DEVICE WITH CLEAR CAP | 2020-04-16 |