Patient Monitor 6500
Basic Information
- Brand Name
- Patient Monitor 6500
- Primary DI
- 00884838107809
- Version / Model
- Patient Monitor
- Catalog Number
- 867315
- 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
- 2025-11-11
- Public Version
- 1
- Public Version Date
- 2025-11-19
- Public Version Status
- New
- Public Device Record Key
- c3c2c771-4d4c-4709-99f5-bfcbcaebb8aa
Device Description
The Patient Monitors 6100, 6300 and 6500 (aka Evoline Patient Monitors) are compact, portable and stationary units with TFT LCD flat panel display (10 inch and 15 inch and built-in CPU. The Monitors are outfitted with a touchscreen interface with multi-finger touch screen capability as their primary input. The patient monitors have integrated physiological measurements such as ECG/Resp, SPO2, NIBP, IBP and Temperature. In addition to their integrated physiological measurements, the Patient Monitors can extend their measurement capabilities by connecting to external measurements via their dedicated [1]Measurement Rack 6000 (867317) and their integrated FlexLink connector. The Patient Monitors run on mains power or on internal battery. The Patient Monitors operate in hospital transport environments and can communicate with the Central Station via LAN or wireless link.
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 | 00884838107809 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250453 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 55 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 57 – 107.5 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity