BIGFOOT BIOMEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3016525500	3016525500	BIGFOOT BIOMEDICAL, INC.	1	N	2026-01-01	1820 McCarthy Boulevard 1820 McCarthy Blvd Milpitas CA US 95035

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00850003506531	Bigfoot Unity - Bigfoot Unity Pen Cap for Lispro	888-523-3662	customercare@bigfootbiomedical.com
00850003506548	Bigfoot Unity - Bigfoot Unity Pen Cap for Lyumjev	888-523-3662	customercare@bigfootbiomedical.com
00850003506555	Bigfoot Unity - Bigfoot Unity Pen Cap for Admelog	888-523-3662	customercare@bigfootbiomedical.com

bigfootbiomedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
345173	1158407216	K221383	MedtFine Blood Lancet	QRK	2022-09-21
345173	1645037081	K202145	Bigfoot Unity Diabetes Management System	QLG	2021-05-07
345173	1350018230	K152365	AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System	NBW	2016-04-21
345173	2016556843	K152339	Unifine Pentips/ Unifine Pentips Plus	FMI	2016-06-24
345173	1444617922
345173	1607738642

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
NBW	2	2016-04-21
QRK	1	2022-09-21
QLG	1	2021-05-07
FMI	1	2016-06-24

PMN#

Bigfoot Unity® Diabetes Management System
2023-03-01
Bigfoot Biomedical, Inc.
Bigfoot Unity Diabetes Management System
2021-05-07
Bigfoot Biomedical, Inc.

GUDID#

Bigfoot Unity - Bigfoot Unity Pen Cap for Degludec
Bigfoot Biomedical, Inc.
2023-10-09
Bigfoot Unity - Bigfoot Unity Pen Cap for Glargine
Bigfoot Biomedical, Inc.
2023-10-09
Bigfoot Unity - Bigfoot Unity Pen Cap for Lispro
Bigfoot Biomedical, Inc.
2023-04-03
Bigfoot Unity - Bigfoot Unity Pen Cap for Lyumjev
Bigfoot Biomedical, Inc.
2023-04-03
Bigfoot Unity - Bigfoot Unity Pen Cap for Admelog
Bigfoot Biomedical, Inc.
2023-04-03
Bigfoot Unity - Bigfoot Unity Pen Cap for Aspart
Bigfoot Biomedical, Inc.
2023-04-03
Bigfoot Unity - Bigfoot Unity Pen Cap for Humalog
Bigfoot Biomedical, Inc.
2023-04-03
Bigfoot Unity - Bigfoot Unity Pen Cap for Apidra
Bigfoot Biomedical, Inc.
2023-04-03
Bigfoot Unity - Bigfoot Unity Pen Cap for NovoLog
Bigfoot Biomedical, Inc.
2023-04-03
Bigfoot Unity - Bigfoot Unity Pen Cap for Tresiba
Bigfoot Biomedical, Inc.
2023-04-03
Bigfoot Unity - Bigfoot Unity Pen Cap for Lantus
Bigfoot Biomedical, Inc.
2023-04-03
Bigfoot Unity - Bigfoot Unity Pen Cap for Fiasp
Bigfoot Biomedical, Inc.
2023-04-03
Bigfoot Unity - Bigfoot Unity Pen Cap for Basaglar
Bigfoot Biomedical, Inc.
2023-04-03
Bigfoot Unity - Bigfoot Unity Pen Cap for Toujeo
Bigfoot Biomedical, Inc.
2023-04-03
Bigfoot Unity - Bigfoot Unity Pen Cap for Toujeo Max
Bigfoot Biomedical, Inc.
2023-04-03
Bigfoot Unity - Bigfoot Unity Program Kit
Bigfoot Biomedical, Inc.
2023-03-30
Bigfoot Unity Diabetes Management System - Bigfoot Unity Diabetes Management System Mobile Application
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Cap for Humalog-Lispro-Lyumjev
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Cap for Basaglar
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Cap for Apidra/Admelog
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Cap for Lantus/Glargine
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Cap for Fiasp
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Cap for Levemir FlexTouch/Tresiba/Degludec
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Cap for Novolog-Aspart
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Cap for Toujeo
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Cap for Toujeo Max
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Diabetes Management System for Humalog-Lispro-Lyumjev and Basaglar Only
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Diabetes Management System for Humalog-Lispro-Lyumjev and Lantus-Glargine Only
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Diabetes Management System for Humalog-Lispro-Lyumjev and Toujeo Only
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Diabetes Management System for Humalog-Lispro-Lyumjev and Toujeo-Max Only
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Diabetes Management System for Humalog-Lispro-Lyumjev and Levemir-Tresiba-Degludec Only
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Diabetes Management System for Apidra-Admelog and Basaglar Only
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Diabetes Management System for Apidra-Admelog and Lantus-Glargine Only
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Diabetes Management System for Apidra-Admelog and Toujeo Only
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Diabetes Management System for Apidra-Admelog and Toujeo Max Only
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Diabetes Management System for Apidra-Admelog and Levemir-Tresiba-Degludec Only
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Diabetes Management System for Fiasp and Basaglar Only
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Diabetes Management System for Fiasp and Lantus-Glargine Only
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Diabetes Management System for Fiasp and Toujeo Only
Bigfoot Biomedical, Inc.
2021-06-29
Bigfoot Unity Diabetes Management System - Bigfoot Unity Diabetes Management System for Fiasp and Toujeo Max Only
Bigfoot Biomedical, Inc.
2021-06-29

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