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Bigfoot Unity Diabetes Management System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K202145

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 Diabetes Management System for Novolog-Aspart and Toujeo Only FDA UDI
Model / Reference
FG-300204 FDA UDI
Description
Bigfoot Unity Diabetes Management System for Novolog-Aspart and Toujeo Only FDA UDI

Identifiers

Catalog Number
FG-300204 FDA UDI
Primary DI / UDI-DI
00850003506388 FDA UDI
510(k) Number
K202145 FDA 510(k)FDA UDI
FDA Product Code
QLG FDA 510(k)FDA UDI
QOG FDA UDI
GMDN Term
Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 862.1355 FDA 510(k)
Regulation Number
862.1355 FDA 510(k)FDA UDI
880.5860 FDA UDI
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Bigfoot Unity Diabetes Management System by Bigfoot Biomedical, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bigfoot Biomedical, Inc.

Sources (2)

  • FDA 510(k) K202145 24 fields · synced Jun 18, 2026
  • FDA UDI b2de982a-1d51-4680-840b-3264b75e2aec 36 fields · synced May 27, 2026