What is FDA product code QLG?

An integrated continuous glucose monitoring system for replacement of finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes, unless otherwise indicated. The system automatically measures glucose in bodily fluids continuously or frequently for a specified period of time. The system is also designed to reliably and securely transmit glucose measurement data to digitally connected devices and are intended to be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The system is not intended to be used with automated insulin dosing (AID) systems.

Bigfoot Unity · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not for Use with Automated Insulin Delivery Systems → Clinical Chemistry

Name: Bigfoot Unity
Brand: Bigfoot Unity

1manufacturer

15catalogue numbers in this listing

2510(k) clearances naming this product code

1recall

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code QLG
Manufacturer	City	Province	Registered as	Device types
Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	6

Record

Regulatory record for Bigfoot Unity
Listed by	Bigfoot Biomedical, Inc., United States
FDA product code	QLG
Device type	Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Device class	Class 2
Regulation	21 CFR 862.1355
Establishment	Specification developer, Repacker / relabeller, Manufacturer
510(k)	K202145
Record published	2023-04-03
Record revised	2025-07-14 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date, serial number
Storage	Storage environment humidity 10 to 90 % RH; Storage environment temperature -13 to 158 °F

Catalogue Numbers

Catalogue numbers for Bigfoot Unity
Catalogue number	Size	Status
FG-301191		In distribution
FG-300993		In distribution
FG-301192		In distribution
FG-301188		In distribution
FG-301189		In distribution
FG-300994		In distribution
FG-301184		In distribution
FG-300995		In distribution
FG-300996		In distribution
FG-301185		In distribution
FG-301190		In distribution
FG-300999		In distribution
FG-301187		In distribution
FG-300992		In distribution
FG-300997		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Bigfoot Unity Diabetes Management System	Bigfoot Biomedical, Inc.	39
FreeStyle Libre 2	Abbott Diabetes Care Limited	4
FreeStyle Libre 3	Abbott Diabetes Care Limited	2
FreeStyle Libre 3 App	Abbott Diabetes Care Limited	2
Libre App	Abbott Diabetes Care Limited	1
FreeStyle Libre 2 App	Abbott Diabetes Care Limited	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K222280	2023-03-01
K202145	2021-05-07

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Bigfoot Unity
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Bigfoot Biomedical, Inc.	510(k) number	2025-05-21	Class II	Software design	Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose a potential health risk for people living with diabetes as	57 pen caps

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Bigfoot Unity