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Bigfoot Unity Diabetes Management System

FDA UDI

Class II (US FDA UDI)

by Bigfoot Biomedical, Inc.

Identity

Trade Name
Bigfoot Unity Diabetes Management System FDA UDI
Generic Name
Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
Device Name
Bigfoot Unity Cap for Basaglar FDA UDI
Model / Reference
ASM-10043 FDA UDI
Description
Bigfoot Unity Cap for Basaglar FDA UDI

Identifiers

Catalog Number
ASM-10043 FDA UDI
Primary DI / UDI-DI
00850003506128 FDA UDI
510(k) Number
K202145 FDA UDI
FDA Product Code
QLG FDA UDI
QOG FDA UDI
GMDN Term
Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1355 FDA UDI
880.5860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical

Bigfoot Unity Diabetes Management System by Bigfoot Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Percutaneous interstitial fluid glucose monitoring system, electrochemical.

Cleared under the same submission

K202145 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bigfoot Biomedical, Inc.

Sources (1)

  • FDA UDI c7b66d42-a7b9-4728-9315-b2208ae8a114 35 fields · synced May 30, 2026