Patient Monitor
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Patient Monitor FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- Patient Monitor EUDAMED
- Model / Reference
- PC-3000 EUDAMEDFDA UDIAIVIEW V10、PH10、LeMonitor V10、AIVIEW V12、PH12、LeMonitor V12 EUDAMEDAIVIEW V12 EUDAMEDPC-3000、Deluxe-70 EUDAMEDK10、K12、K15 EUDAMEDK15 EUDAMEDUP-7000、Advance-120 EUDAMEDUP-7000 EUDAMEDLeMonitor V10 EUDAMEDPH10 EUDAMEDAIView VX、AT10、LeMonitor VX、MT10 EUDAMEDAIView VX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941900600881 EUDAMED06941900606500 EUDAMED06941900606555 EUDAMED06941900606517 EUDAMED06941900600874 EUDAMED06941900600867 EUDAMED06941900606654 EUDAMED06941900604285 FDA UDI
- Basic UDI-DI
- 69419006AIVIEWV12S01QX EUDAMED69419006PC30000179 EUDAMED69419006K15S01AK EUDAMED69419006UP700001JR EUDAMED69419006AIViewVX01D8 EUDAMED
- Direct Marketing DI
- 06941900600881 EUDAMED06941900606500 EUDAMED06941900606555 EUDAMED06941900606517 EUDAMED06941900600874 EUDAMED06941900600867 EUDAMED06941900606654 EUDAMED
- 510(k) Number
- FDA Product Code
- MWI FDA 510(k)FDA UDIDQA FDA UDIDXN FDA UDICCK FDA UDI
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMEDZ1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.2300 FDA 510(k)
- Regulation Number
- 870.2300 FDA 510(k)FDA UDI870.2700 FDA UDI870.1130 FDA UDI868.1400 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
This device is a Multiparameter Patient Monitor (Product Code: MWI), designed to continuously measure and display multiple physiological parameters for patient assessment. It provides real-time monitoring of vital signs such as ECG, pulse oximetry, and other critical indicators to support clinical decision-making in acute and chronic care settings.
The Patient Monitor is supplied as a portable, multiparameter device with a touch-screen interface, intended for use in hospital wards, clinics, emergency rooms, and home care environments. It is intended for single-use or reusable applications, as specified by the manufacturer, and adheres to FDA 510(k) clearance (K123711) and MDR regulatory requirements. The device’s design includes advanced technology for streamlined workflow integration, though specific sterility or MRI safety classifications are not detailed in the provided data.
Frequently asked questions
What types of vital signs can this Patient Monitor continuously track and display in real-time?
This Patient Monitor is designed to continuously measure and display multiple physiological parameters, including ECG (electrocardiogram) and pulse oximetry. While the exact list of monitored indicators isn’t fully detailed, it is classified as a Multiparameter Patient Monitor, meaning it supports critical assessments like heart rate, oxygen saturation, and other vital signs relevant to acute and chronic care settings.
Is this device portable, and where is it typically used in clinical settings?
Yes, the Patient Monitor is explicitly described as a portable device with a touch-screen interface. It is intended for use in a variety of environments, including hospital wards, clinics, emergency rooms, and even home care settings, making it versatile for both inpatient and outpatient monitoring.
How is this device regulated, and what does the FDA’s 510(k) clearance (K123711) mean for its use?
This device holds FDA 510(k) clearance under K123711, which means it has been determined to be substantially equivalent to a legally marketed device already on the market. This clearance supports its use in clinical settings in the U.S. under the specified indications for monitoring multiple physiological parameters. The MDR (Medical Device Regulation) compliance also applies, ensuring adherence to EU regulatory standards if marketed there.
Can this monitor be reused, or is it intended for single-use only?
The device is intended for either single-use or reusable applications, depending on the manufacturer’s specifications for each use case. While the data does not specify sterilization requirements, the flexibility in usage suggests it may be designed for both scenarios, allowing facilities to choose based on their infection control protocols and workflow needs.
What kind of workflow integration features does this monitor include, and how might that benefit clinicians?
The Patient Monitor includes advanced technology for streamlined workflow integration, though the exact features aren’t detailed. This likely means it is designed to reduce clinician burden by offering intuitive controls, quick parameter adjustments, and potentially seamless connectivity with electronic health records (EHRs) or other hospital systems, improving efficiency in acute and chronic care environments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Shenzhen Creative Industry Co., Ltd Lepu-Creative: Remote Patient ..., Vital Signs Monitor - SHENZHEN CREATIVE INDUSTRY CO., LTD., Shenzhen Creative Industry Co., Ltd., Patient Monitor, Patient Monitor direct from Shenzhen Creative Industry ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K123711 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Creative Industry Co., Ltd.
Sources (9)
- FDA 510(k) K123711 24 fields · synced Sep 18, 2026
- FDA UDI c96e44b3-21fa-4375-bbec-ba8035af5a9f 33 fields · synced May 30, 2026
- EUDAMED 69bfa1c7-9684-4fd7-a844-b7028078d9aa 61 fields · synced Jul 9, 2026
- EUDAMED 444e0f6f-fd1e-4e2c-9560-27ca893f143d 61 fields · synced Jul 15, 2026
- EUDAMED 5d5469b9-947b-4c02-95d1-89de0b186dc5 61 fields · synced Jul 15, 2026
- EUDAMED 83d60904-baa7-40e4-b23e-7a3769841c22 61 fields · synced Jul 18, 2026
- EUDAMED 630a9f60-92ea-40c8-af9f-a7dbdfe784de 61 fields · synced Jul 19, 2026
- EUDAMED c3d83241-af85-4403-93bf-d4fc3cc9fa39 61 fields · synced Jul 25, 2026
- EUDAMED e65f7010-f627-4a2b-b8ff-9fd3e19acc68 61 fields · synced Sep 18, 2026