Bigfoot Unity FG-301192
GUDID 00850003506685
Bigfoot Unity Pen Cap for Toujeo Max
Bigfoot Biomedical, Inc.
Percutaneous interstitial-fluid glucose monitoring system, electrochemical| Primary Device ID | 00850003506685 |
| NIH Device Record Key | 3ff641c6-73ca-41e1-b856-f301c15e3ee6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bigfoot Unity |
| Version Model Number | FG-301192 |
| Catalog Number | FG-301192 |
| Company DUNS | 079721177 |
| Company Name | Bigfoot Biomedical, 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 888-523-3662 |
| customercare@bigfootbiomedical.com | |
| Phone | 888-523-3662 |
| customercare@bigfootbiomedical.com | |
| Phone | 888-523-3662 |
| customercare@bigfootbiomedical.com | |
| Phone | 888-523-3662 |
| customercare@bigfootbiomedical.com | |
| Phone | 888-523-3662 |
| customercare@bigfootbiomedical.com | |
| Phone | 888-523-3662 |
| customercare@bigfootbiomedical.com | |
| Phone | 888-523-3662 |
| customercare@bigfootbiomedical.com | |
| Phone | 888-523-3662 |
| customercare@bigfootbiomedical.com | |
| Phone | 888-523-3662 |
| customercare@bigfootbiomedical.com | |
| Phone | 888-523-3662 |
| customercare@bigfootbiomedical.com | |
| Phone | 888-523-3662 |
| customercare@bigfootbiomedical.com | |
| Phone | 888-523-3662 |
| customercare@bigfootbiomedical.com | |
| Phone | 888-523-3662 |
| customercare@bigfootbiomedical.com | |
| Phone | 888-523-3662 |
| customercare@bigfootbiomedical.com | |
| Phone | 888-523-3662 |
| customercare@bigfootbiomedical.com | |
| Phone | 888-523-3662 |
| customercare@bigfootbiomedical.com | |
| Phone | 888-523-3662 |
| customercare@bigfootbiomedical.com |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850003506685 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202145
FDA Product Code
| QLG | Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-11 |
| Device Publish Date | 2023-04-03 |
On-Brand Devices [Bigfoot Unity]
| 00850003506524 | Bigfoot Unity Program Kit |
| 00850003506685 | Bigfoot Unity Pen Cap for Toujeo Max |
| 00850003506678 | Bigfoot Unity Pen Cap for Toujeo |
| 00850003506661 | Bigfoot Unity Pen Cap for Basaglar |
| 00850003506654 | Bigfoot Unity Pen Cap for Fiasp |
| 00850003506647 | Bigfoot Unity Pen Cap for Lantus |
| 00850003506630 | Bigfoot Unity Pen Cap for Tresiba |
| 00850003506623 | Bigfoot Unity Pen Cap for NovoLog |
| 00850003506616 | Bigfoot Unity Pen Cap for Apidra |
| 00850003506609 | Bigfoot Unity Pen Cap for Humalog |
| 00850003506562 | Bigfoot Unity Pen Cap for Aspart |
| 00850003506555 | Bigfoot Unity Pen Cap for Admelog |
| 00850003506548 | Bigfoot Unity Pen Cap for Lyumjev |
| 00850003506531 | Bigfoot Unity Pen Cap for Lispro |
| 00850003506593 | Bigfoot Unity Support Kit |
| 00850003506586 | Bigfoot Unity Pen Cap for Glargine |
| 00850003506579 | Bigfoot Unity Pen Cap for Degludec |
Trademark Results [Bigfoot Unity]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIGFOOT UNITY 88333195 not registered Live/Pending |
Bigfoot Biomedical, Inc. 2019-03-10 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.