FreeStyle Libre 3 Plus
FreeStyle Libre 3 PLUS Sensor NFRS
1manufacturer
5catalogue numbers in this listing
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.
| 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) | K222447 |
| Record published | 2024-07-16 |
| Record revised | 2025-12-24 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| 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 number | Size | Status |
|---|---|---|
| 78768 | In distribution | |
| 78769 | In distribution | |
| 78769-01 | In distribution | |
| 78769 | In distribution | |
| 78768 | 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 |
| 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 |
| 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 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Abbott Diabetes Care Limited | UDI-DI | 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 | UDI-DI | 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.