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 - 00850003506272 Catalog Number : FG-300191

Device Description : Bigfoot Unity Diabetes Management System for Apidra-Admelog 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 - 00850003506289 Catalog Number : FG-300192

Device Description : Bigfoot Unity Diabetes Management System for Apidra-Admelog 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 - 00850003506296 Catalog Number : FG-300193

Device Description : Bigfoot Unity Diabetes Management System for Apidra-Admelog 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 - 00850003506302 Catalog Number : FG-300194

Device Description : Bigfoot Unity Diabetes Management System for Apidra-Admelog 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 - 00850003506319 Catalog Number : FG-300196

Device Description : Bigfoot Unity Diabetes Management System for Fiasp and 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 - 00850003506326 Catalog Number : FG-300197

Device Description : Bigfoot Unity Diabetes Management System for Fiasp 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 - 00850003506333 Catalog Number : FG-300198

Device Description : Bigfoot Unity Diabetes Management System for Fiasp 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 - 00850003506340 Catalog Number : FG-300199

Device Description : Bigfoot Unity Diabetes Management System for Fiasp 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 - 00850003506357 Catalog Number : FG-300200

Device Description : Bigfoot Unity Diabetes Management System for Fiasp 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 - 00850003506364 Catalog Number : FG-300202

Device Description : Bigfoot Unity Diabetes Management System for Novolog-Aspart and Basaglar Only

Device Class : 2

Duns Number: 079721177

Premarket Exempt : No

Product Code : QLG, QOG

Prescription Use : Yes

Device Count : 1

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