| Primary Device ID | 00850003506104 | 
| NIH Device Record Key | 1d75e2e6-f436-46a9-9d21-0dcb07c134db | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Bigfoot Lancets 33 Gauge | 
| Version Model Number | FG-300294 | 
| Catalog Number | FG-300294 | 
| 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 | 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 | false | 
| Phone | 551-244-3668 | 
| customercare@bigfootbiomedical.com | |
| Phone | 551-244-3668 | 
| customercare@bigfootbiomedical.com | |
| Phone | 551-244-3668 | 
| customercare@bigfootbiomedical.com | |
| Phone | 551-244-3668 | 
| customercare@bigfootbiomedical.com | |
| Phone | 551-244-3668 | 
| customercare@bigfootbiomedical.com | |
| Phone | 551-244-3668 | 
| customercare@bigfootbiomedical.com | |
| Phone | 551-244-3668 | 
| customercare@bigfootbiomedical.com | |
| Phone | 551-244-3668 | 
| customercare@bigfootbiomedical.com | |
| Phone | 551-244-3668 | 
| customercare@bigfootbiomedical.com | |
| Phone | 551-244-3668 | 
| customercare@bigfootbiomedical.com | |
| Phone | 551-244-3668 | 
| customercare@bigfootbiomedical.com | |
| Phone | 551-244-3668 | 
| customercare@bigfootbiomedical.com | |
| Phone | 551-244-3668 | 
| customercare@bigfootbiomedical.com | |
| Phone | 551-244-3668 | 
| customercare@bigfootbiomedical.com | |
| Phone | 551-244-3668 | 
| customercare@bigfootbiomedical.com | |
| Phone | 551-244-3668 | 
| customercare@bigfootbiomedical.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00850003506104 [Primary] | 
| FMK | Lancet, Blood | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-07-07 | 
| Device Publish Date | 2021-06-29 | 
| 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 | 
| 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 |