What is FDA product code QBJ?

An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.

Instinct · Integrated Continuous Glucose Monitoring System, Factory Calibrated → Clinical Chemistry

Name: Instinct
Brand: Instinct

1manufacturer

1catalogue number

3510(k) clearances naming this product code

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 QBJ
Manufacturer	City	Province	Registered as	Device types
Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	6

Record

Regulatory record for Instinct
Listed by	Abbott Diabetes Care Limited, United Kingdom
FDA product code	QBJ
Device type	Integrated Continuous Glucose Monitoring System, Factory Calibrated
Device class	Class 2
Regulation	21 CFR 862.1355
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K233537
Record published	2025-09-22
Record revised	2025-12-25 (version 2)

Specifications

Specifications
MRI safety	MR Safe
Sterilisation	Radiation Sterilization
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, serial number
Storage	Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature 36 to 82 °F; Storage environment humidity 10 to 90 % RH
Packaging	Case of 48

Catalogue Numbers

Catalogue numbers for Instinct
Catalogue number	Size	Status
78893		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System	Dexcom, Inc.	6
Dexcom G6 Receiver	Dexcom, Inc.	5
Dexcom G7 GSS	Dexcom, Inc.	5
FreeStyle Libre 3 Plus	Abbott Diabetes Care Limited	5
Dexcom G7 Receiver	Dexcom, Inc.	4
FreeStyle Libre 2 Plus	Abbott Diabetes Care Limited	4
Dexcom G7 GSS (161)	Dexcom, Inc.	4
Dexcom G7 GSS (160)	Dexcom, Inc.	4
FreeStyle Libre 3	Abbott Diabetes Care Limited	3
Dexcom G7 GSS (155)	Dexcom, Inc.	2
Dexcom G6 Transmitter	Dexcom, Inc.	2
Dexcom G7 Sample Pack (160)	Dexcom, Inc.	1

Showing 12 of 36. All products under Integrated Continuous Glucose Monitoring System, Factory Calibrated

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K233537	2024-04-23
K223435	2023-04-13
K222447	2023-03-03

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.

Instinct