Bigfoot Unity FG-300993

GUDID 00850003506593

Bigfoot Unity Support Kit

Bigfoot Biomedical, Inc.

Glucose monitoring system IVD, home-use

• Primary Device ID: 00850003506593
• NIH Device Record Key: 6f07c50e-cf01-4e48-9a22-bf70ada66316
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bigfoot Unity
• Version Model Number: FG-300993
• Catalog Number: FG-300993
• 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: true
• 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: false

Customer Support Contacts

• Phone: 888-523-3662
• Email: customercare@bigfootbiomedical.com
• Phone: 888-523-3662
• Email: customercare@bigfootbiomedical.com
• Phone: 888-523-3662
• Email: customercare@bigfootbiomedical.com
• Phone: 888-523-3662
• Email: customercare@bigfootbiomedical.com
• Phone: 888-523-3662
• Email: customercare@bigfootbiomedical.com
• Phone: 888-523-3662
• Email: customercare@bigfootbiomedical.com
• Phone: 888-523-3662
• Email: customercare@bigfootbiomedical.com
• Phone: 888-523-3662
• Email: customercare@bigfootbiomedical.com
• Phone: 888-523-3662
• Email: customercare@bigfootbiomedical.com
• Phone: 888-523-3662
• Email: customercare@bigfootbiomedical.com
• Phone: 888-523-3662
• Email: customercare@bigfootbiomedical.com
• Phone: 888-523-3662
• Email: customercare@bigfootbiomedical.com
• Phone: 888-523-3662
• Email: customercare@bigfootbiomedical.com
• Phone: 888-523-3662
• Email: customercare@bigfootbiomedical.com
• Phone: 888-523-3662
• Email: customercare@bigfootbiomedical.com
• Phone: 888-523-3662
• Email: customercare@bigfootbiomedical.com
• Phone: 888-523-3662
• Email: customercare@bigfootbiomedical.com
• Phone: 888-523-3662
• Email: customercare@bigfootbiomedical.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003506593 [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: 2023-07-20
• Device Publish Date: 2023-07-12

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