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 - 00850003506166 Catalog Number : ASM-10049

Device Description : Bigfoot Unity Cap for Levemir FlexTouch/Tresiba

Device Class : 2

Duns Number: 079721177

Premarket Exempt : No

Product Code : QLG, QOG

Prescription Use : Yes

Device Count : 1

Bigfoot Unity Diabetes Management System - 00850003506173 Catalog Number : ASM-10046

Device Description : Bigfoot Unity Cap for Novolog-Aspart

Device Class : 2

Duns Number: 079721177

Premarket Exempt : No

Product Code : QOG, QLG

Prescription Use : Yes

Device Count : 1

Bigfoot Unity Diabetes Management System - 00850003506197 Catalog Number : ASM-10053

Device Description : Bigfoot Unity Cap for Toujeo

Device Class : 2

Duns Number: 079721177

Premarket Exempt : No

Product Code : QLG, QOG

Prescription Use : Yes

Device Count : 1

Bigfoot Unity Diabetes Management System - 00850003506203 Catalog Number : ASM-10060

Device Description : Bigfoot Unity Cap for Toujeo Max

Device Class : 2

Duns Number: 079721177

Premarket Exempt : No

Product Code : QLG, QOG

Prescription Use : Yes

Device Count : 1

Bigfoot Unity Diabetes Management System - 00850003506210 Catalog Number : FG-300184

Device Description : Bigfoot Unity Diabetes Management System for Humalog-Lispro-Lyumjev 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 - 00850003506227 Catalog Number : FG-300185

Device Description : Bigfoot Unity Diabetes Management System for Humalog-Lispro-Lyumjev 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 - 00850003506234 Catalog Number : FG-300186

Device Description : Bigfoot Unity Diabetes Management System for Humalog-Lispro-Lyumjev 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 - 00850003506241 Catalog Number : FG-300187

Device Description : Bigfoot Unity Diabetes Management System for Humalog-Lispro-Lyumjev 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 - 00850003506258 Catalog Number : FG-300188

Device Description : Bigfoot Unity Diabetes Management System for Humalog-Lispro-Lyumjev and Levemir- Bigfoot Unity Diabetes Management System for Humalog-Lispro-Lyumjev 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 - 00850003506265 Catalog Number : FG-300190

Device Description : Bigfoot Unity Diabetes Management System for Apidra-Admelog 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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