Bigfoot Unity Diabetes Management System FG-300191

GUDID 00850003506272

Bigfoot Unity Diabetes Management System for Apidra-Admelog and Lantus Only

Bigfoot Biomedical, Inc.

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• Primary Device ID: 00850003506272
• NIH Device Record Key: 5d77a56f-7af6-42ab-8c16-5f32fdb2e14a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bigfoot Unity Diabetes Management System
• Version Model Number: FG-300191
• Catalog Number: FG-300191
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003506272 [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: 2021-07-07
• Device Publish Date: 2021-06-29

On-Brand Devices [Bigfoot Unity Diabetes Management System]

• 00850003506494: Bigfoot Unity Diabetes Management System Cap for Levemir FlexTouch/Tresiba Only
• 00850003506487: Bigfoot Unity Diabetes Management System Cap for Toujeo Max Only
• 00850003506470: Bigfoot Unity Diabetes Management System Cap for Toujeo Only
• 00850003506463: Bigfoot Unity Diabetes Management System Cap for Lantus Only
• 00850003506456: Bigfoot Unity Diabetes Management System Cap for Basaglar Only
• 00850003506449: Bigfoot Unity Diabetes Management System Cap for Novolog Only
• 00850003506432: Bigfoot Unity Diabetes Management System Cap for Fiasp Only
• 00850003506425: Bigfoot Unity Diabetes Management System Cap for Apidra/Admelog Only
• 00850003506418: Bigfoot Unity Diabetes Management System Cap for Humalog Only
• 00850003506401: Bigfoot Unity Diabetes Management System for Novolog and Levemir-Tresiba Only
• 00850003506395: Bigfoot Unity Diabetes Management System for Novolog and Toujeo Max Only
• 00850003506388: Bigfoot Unity Diabetes Management System for Novolog and Toujeo Only
• 00850003506371: Bigfoot Unity Diabetes Management System for Novolog and Lantus Only
• 00850003506364: Bigfoot Unity Diabetes Management System for Novolog and Basaglar Only
• 00850003506357: Bigfoot Unity Diabetes Management System for Fiasp and Levemir-Tresiba Only
• 00850003506340: Bigfoot Unity Diabetes Management System for Fiasp and Toujeo Max Only
• 00850003506333: Bigfoot Unity Diabetes Management System for Fiasp and Toujeo Only
• 00850003506326: Bigfoot Unity Diabetes Management System for Fiasp and Lantus Only
• 00850003506319: Bigfoot Unity Diabetes Management System for Fiasp and Basaglar Only
• 00850003506302: Bigfoot Unity Diabetes Management System for Apidra-Admelog and Levemir-Tresiba Only
• 00850003506296: Bigfoot Unity Diabetes Management System for Apidra-Admelog and Toujeo Max Only
• 00850003506289: Bigfoot Unity Diabetes Management System for Apidra-Admelog and Toujeo Only
• 00850003506272: Bigfoot Unity Diabetes Management System for Apidra-Admelog and Lantus Only
• 00850003506265: Bigfoot Unity Diabetes Management System for Apidra-Admelog and Basaglar Only
• 00850003506258: Bigfoot Unity Diabetes Management System for Humalog and Levemir-Tresiba Only
• 00850003506241: Bigfoot Unity Diabetes Management System for Humalog and Toujeo-Max Only
• 00850003506234: Bigfoot Unity Diabetes Management System for Humalog and Toujeo Only
• 00850003506227: Bigfoot Unity Diabetes Management System for Humalog and Lantus Only
• 00850003506210: Bigfoot Unity Diabetes Management System for Humalog and Basaglar Only
• 00850003506203: Bigfoot Unity Cap for Toujeo Max
• 00850003506197: Bigfoot Unity Cap for Toujeo
• 00850003506173: Bigfoot Unity Cap for Novolog
• 00850003506166: Bigfoot Unity Cap for Levemir FlexTouch/Tresiba
• 00850003506159: Bigfoot Unity Cap for Fiasp
• 00850003506142: Bigfoot Unity Cap for Lantus
• 00850003506135: Bigfoot Unity Cap for Apidra/Admelog
• 00850003506128: Bigfoot Unity Cap for Basaglar
• 00850003506111: Bigfoot Unity Cap for Humalog
• 00850003506074: Bigfoot Unity Diabetes Management System Mobile Application