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) (3) Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (QLG) (3) System, Test, Blood Glucose, Over The Counter (NBW) (1)

Premarket Exempt

No Yes

Clear

Bigfoot Unity Diabetes Management System - 00850003506470 Catalog Number : FG-300177

Device Description : Bigfoot Unity Diabetes Management System Cap for Toujeo Only

Device Class : 2

Duns Number: 079721177

Premarket Exempt : No

Product Code : QLG, QOG

Prescription Use : Yes

Device Count : 1

Bigfoot Unity Diabetes Management System - 00850003506487 Catalog Number : FG-300178

Device Description : Bigfoot Unity Diabetes Management System Cap for Toujeo Max Only

Device Class : 2

Duns Number: 079721177

Premarket Exempt : No

Product Code : QLG, QOG

Prescription Use : Yes

Device Count : 1

Bigfoot Unity Diabetes Management System - 00850003506494 Catalog Number : FG-300179

Device Description : Bigfoot Unity Diabetes Management System Cap for Levemir FlexTouch/Tresiba Only

Device Class : 2

Duns Number: 079721177

Premarket Exempt : No

Product Code : QLG, QOG

Prescription Use : Yes

Device Count : 1

Bigfoot Test Strips Blood Glucose Test Strips - 30850003506006 Catalog Number : FG-300295

Device Description : Bigfoot Test Strips Blood Glucose Test Strips 50CT

Device Class : 2

Duns Number: 079721177

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

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