FreeStyle Libre 3
FreeStyle Libre 3 Reader is a rechargeable handheld display for the compatible Libre 3 glucose sensor. It starts a sensor through near-field communication and receives glucose data through…
FreeStyle Libre 3 Reader is a rechargeable handheld display for the compatible Libre 3 glucose sensor. It starts a sensor through near-field communication and receives glucose data through Bluetooth Low Energy.
The reader displays sensor glucose information and provides configurable high- or low-glucose alarms. It also has a strip port for compatible FreeStyle Precision Neo blood glucose strips and event-logging functions.
Listed Item
FreeStyle Libre 3 Continuous Glucose Monitoring System Reader
System Use
The prescription system supports diabetes management in people aged two years and older at home. Readings are interpreted with glucose trends and sequential measurements. The reader and smartphone app are alternative primary displays and do not interact with each other.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
Record
| 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) | K223435 |
| Record published | 2025-06-25 |
| Record revised | 2025-11-14 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -4 to 140 °F |
| Packaging | Case of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 72078 | In distribution | |
| 78754 | In distribution | |
| 72079 | In distribution |
Same 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 |
| Dexcom G7 GSS (155) | Dexcom, Inc. | 2 |
| Dexcom G6 Transmitter | Dexcom, Inc. | 2 |
| Dexcom G7 Sample Pack (160) | Dexcom, Inc. | 1 |
| Dexcom G6 Sensor Kit (1) Medicare | Dexcom, Inc. | 1 |
Showing 12 of 36. All products under Integrated Continuous Glucose Monitoring System, Factory Calibrated
510(K) Clearances
| 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.