Bigfoot Meter Blood Glucose Monitoring System FG-10027

GUDID 00850003506036

Bigfoot Meter Blood Glucose Monitoring System

Bigfoot Biomedical, Inc.

Glucose monitoring system IVD, home-use

• Primary Device ID: 00850003506036
• NIH Device Record Key: 7738a9cc-5138-4620-a18e-1b169eb6779c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bigfoot Meter Blood Glucose Monitoring System
• Version Model Number: FG-10027
• Catalog Number: FG-10027
• 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: 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003506036 [Primary]

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

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

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