FDA UDI
In Commercial Distribution
🇺🇸 United States
IntelliVue Patient Monitor MX850
DI: 00884838070790
·
Model: IntelliVue Patient Monitor MX850
·
Philips Medizin Systeme Böblingen GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IntelliVue Patient Monitor MX850
- Primary DI
- 00884838070790
- Version / Model
- IntelliVue Patient Monitor MX850
- Catalog Number
- 866470
- Company Name
- Philips Medizin Systeme Böblingen GmbH
- Labeler DUNS
- 314101143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-29
- Public Version
- 7
- Public Version Date
- 2023-07-28
- Public Version Status
- Update
- Public Device Record Key
- 6927d87b-9863-4512-a95a-d5bdc250ea17
Device Description
The IntelliVue MX850 Patient Monitor has an optically-bonded 22 inch (547 mm) LCD (TFT) widescreen display with projected capacitive touch technology. It is compatible with various measurement modules and measurement servers. The monitor provides as standard a 100BaseT LAN port, an RS232 port, four USB ports, a basic nurse call relay, and an analog ECG sync output. MX850 also provides two MSL connectors for connecting up to two FMX-4 module racks (either in parallel or serial). Built-in to the front of the display is a Contactless ID and Communication module using RFID technology. Please refer to technical data sheet for more information.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Cardiovascular | 870.1025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36872 | Multiple vital physiological parameter monitoring system, clinical | An assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838070790 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 57 – 107.5 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity