Bigfoot Unity Diabetes Management System FG-300187

GUDID 00850003506241

Bigfoot Unity Diabetes Management System for Humalog and Toujeo-Max Only

Bigfoot Biomedical, Inc.

Percutaneous interstitial-fluid glucose monitoring system
Primary Device ID00850003506241
NIH Device Record Key0c5e587e-e45c-4451-8992-5727751692c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBigfoot Unity Diabetes Management System
Version Model NumberFG-300187
Catalog NumberFG-300187
Company DUNS079721177
Company NameBigfoot Biomedical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com
Phone888-523-3662
Emailcustomercare@bigfootbiomedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850003506241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QLGIntegrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-07
Device Publish Date2021-06-29

On-Brand Devices [Bigfoot Unity Diabetes Management System]

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