Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016525500

FEI Number

3016525500

Entity Name

BIGFOOT BIOMEDICAL, INC.

City/State/Country

Milpitas, CA, US

Establishment Address

1820 McCarthy Boulevard, 1820 McCarthy Blvd, Milpitas, CA 95035, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

ABBOTT LABORATORIES (Owner Number: 1415939)

Owner / Operator Contact Address

100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221383

PMA Number

N/A

All Registered Proprietary Names

Bigfoot Alcohol Prep Pads Bigfoot Pen Needles Bigfoot Meter Bigfoot Unity Support Kit Bigfoot Meter Bigfoot Unity Support Kit FreeStyle Libre Pro Software FreeStyle Libre Software LibreView Bigfoot Unity Report Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Lantus-Glargine Only Bigfoot Unity Diabetes Management System- For Fiasp and Levemir-Tresiba-Degludec Only Bigfoot Unity Diabetes Management System- For Fiasp and Basaglar Only Bigfoot Unity Diabetes Management System- For Apidra-Admelog and Toujeo Max Only Bigfoot Unity Diabetes Management System- For Apidra-Admelog and Levemir-Tresiba-Degludec Only Bigfoot Unity Diabetes Management System - Cap for Fiasp Only Bigfoot Unity Diabetes Management System - Cap for Toujeo Max Only Bigfoot Unity-Mobile App Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Toujeo Max Only Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Levemir-Tresiba-Degludec Only Bigfoot Unity Program Kit Bigfoot Unity Diabetes Management System - Cap for Basaglar Only Bigfoot Unity Diabetes Management System- For Apidra-Admelog and Basaglar Only Bigfoot Unity Diabetes Management System - Cap for Novolog-Aspart Only Bigfoot Unity Diabetes Management System - Cap for Humalog-Lispro-Lyumjev Only Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Basaglar Only Bigfoot Unity Diabetes Management System- For Novolog-Aspart and Basaglar Only Bigfoot Unity Diabetes Management System- For Fiasp and Toujeo Max Only Bigfoot Unity Diabetes Management System - Cap for Toujeo Only Bigfoot Unity Diabetes Management System- For Novolog-Aspart and Toujeo Only Bigfoot Unity Diabetes Management System - Cap for Apidra/Admelog Only Bigfoot Unity Diabetes Management System- For Novolog-Aspart and Levemir-Tresiba-Degludec Only Bigfoot Unity Diabetes Management System- For Novolog-Aspart and Toujeo Max Only Bigfoot Unity Diabetes Management System- For Fiasp and Lantus-Glargine Only Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Toujeo Only Bigfoot Unity Diabetes Management System- For Fiasp and Toujeo Only Bigfoot Unity Diabetes Management System- For Apidra-Admelog and Toujeo Only Bigfoot Unity Diabetes Management System- For Novolog-Aspart and Lantus-Glargine Only Bigfoot Unity Diabetes Management System- For Apidra-Admelog and Lantus -Glargine Only Bigfoot Unity Diabetes Management System - Cap for Lantus-Glargine Only Bigfoot Unity Diabetes Management System - Cap for Levemir FlextTouch/Tresiba-Degludec Only Bigfoot Lancet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2023-11-03
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-11-03
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2023-11-03
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2023-11-03
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2023-11-03
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2023-11-03
PHV	Continuous Glucose Monitor Retrospective Data Analysis Software	Clinical Chemistry	Class 1	862.2120	2017-12-07
QLG	Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems	Clinical Chemistry	Class 2	862.1355	2021-05-10
QOG	Injection Data Capture Device	General Hospital	Class 2	880.5860	2021-05-10
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-11-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABBOTT LABORATORIES

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3011706799	Abbott Medical	Atlanta, GA, US
1628664	ABBOTT LABORATORIES	IRVING, TX, US
3023268435	Abbott Automation Solutions GmbH	Hamburg, DE
3001883144	St. Jude Medical Brasil Ltda.	Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K811074	Reagents Applications, Inc.	GLUCOSE REAGENT-ENZYMATIC-COLOR 500	1981-04-29
K936212	Heraeus Kulzer, Inc.	GLUCOFILM TEST STRIPS	1994-05-10
K150396	Apex BioTechnology Corp.	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips	2015-10-14
K150833	Andon Health Co, Ltd.	iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System	2015-12-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0378-06	Instrumentation Laboratory Co.	2	GEM PREMIER 3000
Z-2165-2011	Instrumentation Laboratory Co.	2	Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016525500. Last updated year: 2026. Please use registration number 3016525500 when referencing this establishment in official correspondence.