Stimpod
Neuromuscular blocking agent monitoring cable (3.0m) using acceleromyography. Accessory to be used with the STIMPOD NMS450 Nerve Stimulator.
2manufacturers in China registered for this device type
6catalogue numbers in this listing
6510(k) clearances naming this product 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 | Xavant Technology (PTY) Ltd, South Africa |
|---|---|
| FDA product code | BXN |
| Device type | Stimulator, Nerve, Battery-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2775 |
| Establishment | Manufacturer |
| 510(k) | K213049 |
| Record published | 2022-11-19 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 0 to 50 °C; Storage environment humidity 10 to 90 % RH |
| Packaging | Box of 5, box of 10, box of 15, box of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NMT Monitoring Cable EMG (3.5m) | In distribution | |
| EMG Electrode Small | In distribution | |
| NMT Monitoring Cable EMG (1.8m) | In distribution | |
| EMG Electrode Large | In distribution | |
| NMT Monitoring Cable AMG (3.0m) | In distribution | |
| NMT Monitoring Cable EMG (3.0m) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SunMed | SunMed Group Holdings, LLC | 22 |
| Xavant Technology | Xavant Technology (PTY) Ltd | 14 |
| Stimuplex® | B. Braun Medical Inc. | 12 |
| AincA® | Anesthesia Associates, Inc. | 9 |
| Halyard | Avanos Medical, Inc. | 8 |
| Avanos | Avanos Medical, Inc. | 8 |
| 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 |
|---|---|
| K213049 | 2022-10-16 |
| K140853 | 2014-11-06 |
| K110118 | 2011-02-17 |
| K102084 | 2010-12-16 |
| K093591 | 2009-12-03 |
| K072092 | 2007-11-15 |
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.