Bigfoot Biomedical, Inc.

Address:1820 McCarthy Boulevard,Milpitas,CA,95035,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Injection Data Capture Device (QOG) (6) Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (QLG) (6) Disinfectant, Medical Devices (LRJ) (1) Lancet, Blood (FMK) (1) Needle, Hypodermic, Single Lumen (FMI) (1) System, Test, Blood Glucose, Over The Counter (NBW) (1)

Premarket Exempt

No Yes

Clear

Bigfoot Meter Blood Glucose Monitoring System - 00850003506036 Catalog Number : FG-10027

Device Description : Bigfoot Meter Blood Glucose Monitoring System

Device Class : 2

Duns Number: 079721177

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Bigfoot Pen Needles - 00850003506067 Catalog Number : FG-300161

Device Description : Bigfoot Pen Needles, 4mm 32G, 100CT

Device Class : 2

Duns Number: 079721177

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

Bigfoot Unity Diabetes Management System - 00850003506074 Catalog Number : SW-300842

Device Description : Bigfoot Unity Diabetes Management System Mobile Application

Device Class : 2

Duns Number: 079721177

Premarket Exempt : No

Product Code : QLG, QOG

Prescription Use : No

Device Count : 1

Bigfoot Alcohol Prep Pads, 70% v/v Isopropyl Alcohol - 00850003506081 Catalog Number : FG-300145

Device Description : Bigfoot Alcohol Prep Pads, 70% v/v Isopropyl Alcohol, 100CT

Device Class : 1

Duns Number: 079721177

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Bigfoot Lancets 33 Gauge - 00850003506104 Catalog Number : FG-300294

Device Description : Bigfoot Lancets 33 Gauge, 100CT

Device Class : 2

Duns Number: 079721177

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

Bigfoot Unity Diabetes Management System - 00850003506111 Catalog Number : ASM-10027

Device Description : Bigfoot Unity Cap for Humalog-Lispro-Lyumjev

Device Class : 2

Duns Number: 079721177

Premarket Exempt : No

Product Code : QLG, QOG

Prescription Use : Yes

Device Count : 1

Bigfoot Unity Diabetes Management System - 00850003506128 Catalog Number : ASM-10043

Device Description : Bigfoot Unity Cap for Basaglar

Device Class : 2

Duns Number: 079721177

Premarket Exempt : No

Product Code : QLG, QOG

Prescription Use : Yes

Device Count : 1

Bigfoot Unity Diabetes Management System - 00850003506135 Catalog Number : ASM-10050

Device Description : Bigfoot Unity Cap for Apidra/Admelog

Device Class : 2

Duns Number: 079721177

Premarket Exempt : No

Product Code : QLG, QOG

Prescription Use : Yes

Device Count : 1

Bigfoot Unity Diabetes Management System - 00850003506142 Catalog Number : ASM-10051

Device Description : Bigfoot Unity Cap for Lantus

Device Class : 2

Duns Number: 079721177

Premarket Exempt : No

Product Code : QLG, QOG

Prescription Use : Yes

Device Count : 1

Bigfoot Unity Diabetes Management System - 00850003506159 Catalog Number : ASM-10048

Device Description : Bigfoot Unity Cap for Fiasp

Device Class : 2

Duns Number: 079721177

Premarket Exempt : No

Product Code : QLG, QOG

Prescription Use : Yes

Device Count : 1

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