| Primary Device ID | 00850003506517 |
| NIH Device Record Key | 899f52b5-5f80-4a7f-a662-ce9b42d15055 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bigfoot Unity Report |
| Version Model Number | SW-300983 |
| Catalog Number | SW-300983 |
| Company DUNS | 079721177 |
| Company Name | Bigfoot Biomedical, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 | 00850003506517 [Primary] |
| PHV | Continuous Glucose Monitor Retrospective Data Analysis Software |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-20 |
| Device Publish Date | 2023-07-12 |
| 00850003506579 - Bigfoot Unity | 2023-10-17 Bigfoot Unity Pen Cap for Degludec |
| 00850003506586 - Bigfoot Unity | 2023-10-17 Bigfoot Unity Pen Cap for Glargine |
| 00850003506517 - Bigfoot Unity Report | 2023-07-20 |
| 00850003506517 - Bigfoot Unity Report | 2023-07-20 |
| 00850003506593 - Bigfoot Unity | 2023-07-20 Bigfoot Unity Support Kit |
| 00850003506531 - Bigfoot Unity | 2023-04-11 Bigfoot Unity Pen Cap for Lispro |
| 00850003506548 - Bigfoot Unity | 2023-04-11 Bigfoot Unity Pen Cap for Lyumjev |
| 00850003506555 - Bigfoot Unity | 2023-04-11 Bigfoot Unity Pen Cap for Admelog |
| 00850003506562 - Bigfoot Unity | 2023-04-11 Bigfoot Unity Pen Cap for Aspart |