Stimuplex®
Stimuplex® A, 24 Ga. x 1 in. (25 mm) Insulated Needle with 30° Bevel and Extension Set
2manufacturers in China registered for this device type
12catalogue numbers in this listing
1510(k) clearance
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Easymed Instruments Co., Ltd. | Daliang, Shunde, Foshan | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | B. Braun Medical Inc., United States |
|---|---|
| FDA product code | BXN |
| Device type | Stimulator, Nerve, Battery-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2775 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2020-03-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Distribution end date | 2023-03-29 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4894539 | Gauge (cannula) : 22 | 25 | In distribution |
| 4894251 | Gauge (cannula) : 24 | 25 | In distribution |
| 4894367 | Gauge (cannula) : 22 | 25 | In distribution |
| 4894278 | Gauge (cannula) : 20 | 25 | In distribution |
| 333576 | In distribution | ||
| 4894260 | Gauge (cannula) : 21 | 25 | In distribution |
| 4894502 | Gauge (cannula) : 22 | 25 | In distribution |
| 333544 | In distribution | ||
| 4894260NR-02 | 25 | Withdrawn | |
| 4894278NR-02 | 25 | Withdrawn | |
| 4894251NR-02 | 25 | Withdrawn | |
| 4894502NR-02 | 25 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SunMed | SunMed Group Holdings, LLC | 22 |
| Xavant Technology | Xavant Technology (PTY) Ltd | 14 |
| AincA® | Anesthesia Associates, Inc. | 9 |
| Halyard | Avanos Medical, Inc. | 8 |
| Avanos | Avanos Medical, Inc. | 8 |
| Stimpod | Xavant Technology (PTY) Ltd | 6 |
| Multistim Vario | Pajunk Gmbh Medizintechnologie | 6 |
| Multistim Sensor | Pajunk Gmbh Medizintechnologie | 5 |
| MultiStim ECO | Pajunk Gmbh Medizintechnologie | 4 |
| MultiStim Sensor PatientCable | Pajunk Gmbh Medizintechnologie | 4 |
| Temena | Temena GmbH | 2 |
| Bioness | Xavant Technology (PTY) Ltd | 2 |
Showing 12 of 19. All products under Stimulator, Nerve, Battery-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K021033 | 2003-03-21 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| B. Braun Medical Inc. | UDI-DI | 2024-05-17 | Class II | Component design/selection | The devices are labeled “not made with DEHP” or the DEHP free symbol; however, the glue used contains traces of DEHP. | 20,850 units |
| B. Braun Medical Inc. | UDI-DI | 2024-05-17 | Class II | Component design/selection | The devices are labeled “not made with DEHP” or the DEHP free symbol; however, the glue used contains traces of DEHP. | 1,783,991 units |
| B. Braun Medical Inc. | UDI-DI | 2024-05-17 | Class II | Component design/selection | The devices are labeled “not made with DEHP” or the DEHP free symbol; however, the glue used contains traces of DEHP. | 108,811 units |
| B. Braun Medical Inc. | UDI-DI | 2024-05-17 | Class II | Component design/selection | The devices are labeled “not made with DEHP” or the DEHP free symbol; however, the glue used contains traces of DEHP. | 1,157,640 units |
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.