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) (10) Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (QLG) (10)

Premarket Exempt

No Yes

Clear

Bigfoot Unity Diabetes Management System - 00850003506371 Catalog Number : FG-300203

Device Description : Bigfoot Unity Diabetes Management System for Novolog-Aspart and Lantus 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 - 00850003506388 Catalog Number : FG-300204

Device Description : Bigfoot Unity Diabetes Management System for Novolog-Aspart and 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 - 00850003506395 Catalog Number : FG-300205

Device Description : Bigfoot Unity Diabetes Management System for Novolog-Aspart and 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 - 00850003506401 Catalog Number : FG-300206

Device Description : Bigfoot Unity Diabetes Management System for Novolog-Aspart and Levemir-Tresiba 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 - 00850003506418 Catalog Number : FG-300171

Device Description : Bigfoot Unity Diabetes Management System Cap for Humalog-Lispro-Lyumjev 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 - 00850003506425 Catalog Number : FG-300172

Device Description : Bigfoot Unity Diabetes Management System Cap for Apidra/Admelog 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 - 00850003506432 Catalog Number : FG-300173

Device Description : Bigfoot Unity Diabetes Management System Cap for Fiasp 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 - 00850003506449 Catalog Number : FG-300174

Device Description : Bigfoot Unity Diabetes Management System Cap for Novolog-Aspart 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 - 00850003506456 Catalog Number : FG-300175

Device Description : Bigfoot Unity Diabetes Management System Cap for Basaglar 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 - 00850003506463 Catalog Number : FG-300176

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

Device Class : 2

Duns Number: 079721177

Premarket Exempt : No

Product Code : QLG, QOG

Prescription Use : Yes

Device Count : 1

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