Libre App
The Libre Android app displays glucose information from compatible FreeStyle Libre sensors on a compatible phone. It serves as the primary display for current readings, trends, historical…
The Libre Android app displays glucose information from compatible FreeStyle Libre sensors on a compatible phone. It serves as the primary display for current readings, trends, historical information, and configurable glucose or signal-loss alarms during diabetes management.
The app uses near field communication to start a new sensor and Bluetooth Low Energy to receive its glucose data. It supports Libre 2 and Libre 3 sensor families, including the corresponding Plus sensors.
Listed Item
Libre Android App US
Use Conditions
The system is prescribed for home use. Minimum age depends on the sensor: four years for Libre 2 or 3 and two years for Plus sensors. Treatment decisions use trends and sequential readings, subject to the sensor labeling and circumstances requiring blood glucose testing.
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) | K233537 |
| Record published | 2024-12-17 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Single use | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 78745-01 | 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 |
| 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
| Clearance | Decision date |
|---|---|
| K233537 | 2024-04-23 |
| K223435 | 2023-04-13 |
| K222447 | 2023-03-03 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Abbott Diabetes Care Limited | 510(k) number | 2025-11-24 | Class I | Process control | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results | 1,663,241 sensors |
| Abbott Diabetes Care Limited | 510(k) number | 2025-11-24 | Class I | Process control | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results | 258,913 sensors |
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.