Portrait HUB01
HUB, Ambulatory HUB Device Assembly
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
Record
| Listed by | GE Healthcare Finland OY, Finland |
|---|---|
| FDA product code | MSX |
| Device type | System, Network And Communication, Physiological Monitors |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2300 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K230626 |
| Record published | 2023-09-01 |
| Record revised | 2026-03-09 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 40 °C; Storage environment humidity 5 to 95 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal |
| Distribution end date | 2026-03-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HUB01 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Messenger | Spok Inc. | 9 |
| eCareManager | Visicu, Inc. | 8 |
| Engage Medical Device Alarm Notification System (Emdan) | Stryker GmbH | 8 |
| BeneVision Central Monitoring System | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 7 |
| Xhibit | Spacelabs Healthcare (Washington), Inc | 4 |
| IntelliVue XDS Software | Philips Medizin Systeme Böblingen GmbH | 4 |
| Ascom | Ascom Sweden AB | 3 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 3 |
| Patient SafetyNet Console | Masimo Corporation | 3 |
| System, Network And Communication, Physiological Monitors | Philips Medical Systems Hsg | 3 |
| RescueNet 12-Lead | Zoll Medical Corporation | 2 |
| Telemetry Transmitter | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 2 |
Showing 12 of 165. All products under System, Network And Communication, Physiological Monitors
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| GE Medical Systems Information Technologies, Inc. | 510(k) number | 2026-07-20 | Class II | Device Design | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured fo | 15 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.