Natus
Monitor Adapter Cable, ICP, 10S BURDICK M200 M500 SERIES
5manufacturers in China registered for this device type
15catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Guangdong (3), Shanghai (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Natus Medical Incorporated, United States |
|---|---|
| FDA product code | GWM |
| Device type | Device, Monitoring, Intracranial Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1620 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2024-07-10 |
| Record revised | 2025-12-08 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 025519 | In distribution | |
| 025509 | In distribution | |
| 025505 | In distribution | |
| 025497 | In distribution | |
| 025517 | In distribution | |
| 025515 | In distribution | |
| 025503 | In distribution | |
| 025521 | In distribution | |
| 025511 | In distribution | |
| 025495 | In distribution | |
| 025499 | In distribution | |
| 025501 | In distribution | |
| 025507 | In distribution | |
| CAM03 | In distribution | |
| 025513 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Licox® | GMS, Gesellschaft für medizinische Sondentechnik mbH | 38 |
| Sophysa | Sophysa | 32 |
| Becker® | Medtronic PS Medical | 31 |
| Codman | Cerenovus, Inc. | 29 |
| Device, Monitoring, Intracranial Pressure | Medtronic PS Medical | 28 |
| Exacta™ | Medtronic PS Medical | 28 |
| Braincare | Braincare Desenvolvimento E Inovacao Tecnologica SA | 24 |
| Camino® | Integra Lifesciences (Ireland) Limited | 20 |
| Codman® | Integra LifeSciences Production Corporation | 19 |
| Integra® | Integra Lifesciences (Ireland) Limited | 17 |
| Aura | Branchpoint & Aura Development LLC | 17 |
| Duet® | Medtronic PS Medical | 14 |
Showing 12 of 133. All products under Device, Monitoring, Intracranial Pressure
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2008-01-28 | Not classified | Process design | Incorrect pressure reading: Due to a manufacturing error, the ICP reading could be inaccurate to the extent that they exceed label claims. Specifically, the Insertion Error label claim of +/- 3mmHg could be exceeded by up to -3mmHg, that c | 43 units | 2010-04-22 |
| 2005-09-08 | Not classified | Other | Certain Model NS-P probes contained in the NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit may allow an Intracranial Pressure (ICP) drift of up to 5 mmHg during the first 24 hours of monitoring ICP. This is outsid | 79 | 2012-03-07 |
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.