IntelliVue Hemodynamic Extension
IntelliVue Hemodynamic Extension works together with the IntelliVue Multi-Measurement Module (M3001A/AL), IntelliVue X2 Multi-Measurement Module (M3002A), IntelliVue MP2 Patient Monitor…
IntelliVue Hemodynamic Extension works together with the IntelliVue Multi-Measurement Module (M3001A/AL), IntelliVue X2 Multi-Measurement Module (M3002A), IntelliVue MP2 Patient Monitor (M8102A), IntelliVue X3 (867030) and IntelliVue MX100 (867033). Right Heart Cardiac Output (C.O.), continuous C.O. PiCCO, dual Invasive Pressure and continuous Temperature measurement can be selected via B-options.
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Hebei (1). 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 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Shanghai Draeger Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| General Meditech, Inc. | Shenzhen | Guangdong | Complaint-file establishment | 3 |
Record
| Listed by | Philips Medizin Systeme Böblingen GmbH, Germany |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Record published | 2019-04-11 |
| Record revised | 2025-04-14 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment atmospheric pressure 57 to 107.5 KiloPascal; Storage environment humidity 15 to 90 % RH; Storage environment temperature -20 to 60 °C; Storage environment temperature -4 to 140 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IntelliVue Hemodynamic Extension | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 326 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 266 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden Corp. | 205 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden America, Inc. | 139 |
| Surveyor Central | Mortara Instrument, Inc. | 71 |
| Tempus Pro | Remote Diagnostic Technologies Ltd. | 44 |
| Surveyor S12 | Mortara Instrument, Inc. | 38 |
| Ultraview | Spacelabs Healthcare (Washington), Inc | 29 |
| Surveyor S19 | Mortara Instrument, Inc. | 26 |
| Vital Signs™ | AirLife Finland Oy | 23 |
| Patient Monitor | Edan Instruments, Inc. | 22 |
| Telemetry Accessories | Philips Medizin Systeme Böblingen GmbH | 21 |
Showing 12 of 589. All products under Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251702 | 2025-11-10 |
| K250453 | 2025-09-02 |
| K242962 | 2025-05-05 |
| K221348 | 2023-02-03 |
| K211900 | 2022-03-04 |
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.