IntelliVue GuardianSoftware IGS
by Philips Medizin Systeme Böblingen GmbH Germany EUDAMED510(k)GUDID
Ref 866009Model IGS
Product code DXJEMDN Z12030292
Overview
IntelliVue GuardianSoftware IGS is a monitoring and patient data management software system designed for critical care environments. As a Class IIb medical device, it integrates real-time patient monitoring, alarm management, and clinical decision support to enhance patient safety and workflow efficiency in hospital settings.
The software is non-sterile, non-reusable, and intended for use in clinical environments where continuous patient monitoring is required. It operates as a standalone application or within a larger healthcare IT infrastructure, with no implantable or reprocessing requirements. Authorized under FDA 510K and MDR compliance, it supports standardized UDI identifiers for traceability and regulatory adherence.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0884838BM539TE | Date30 Sep 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00884838094253 | Date20 Dec 2019 | StatusIn distribution |
| United States | FDA 510(k) 510(k) | NumberK180534 | Date16 Jul 2018 | StatusActive |
Coverage
- Active
- Not covered
- United States
- European Union
Specification
- Full name
- IntelliVue GuardianSoftware
- Generic Name
- Medical equipment clinical data interfacing software
- Device Name
- Igs
- Model / Ref / Catalog
- IGS, 866009, E
- Primary DI / UDI-DI
- 00884838094253
- Basic UDI-DI
- 0884838BM539TE
- Direct Marketing DI
- 00884838094253
- FDA Product Code
- DXJ
- EMDN Code
- Z12030292 Vital signs monitoring instruments - medical device software
- GMDN Term
- Medical equipment clinical data interfacing software
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 870.2450
- Market of Registration
- Austria
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | IGS 866009 | E |
| Device Class | Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- DE-MF-000006026
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Questions
What clinical environments is the IntelliVue GuardianSoftware designed to support, and how does it improve patient safety?
The IntelliVue GuardianSoftware is specifically designed for critical care environments where continuous patient monitoring is essential, such as intensive care units (ICUs) and emergency departments. It integrates real-time patient monitoring, advanced alarm management, and clinical decision support tools to help clinicians quickly assess patient status, reduce alert fatigue, and streamline workflows—all of which contribute to enhanced patient safety and timely interventions.
Is the IntelliVue GuardianSoftware reusable or single-use, and what does that mean for maintenance and updates?
The IntelliVue GuardianSoftware is a non-reusable software system, meaning it is intended for continuous use in clinical settings without reprocessing. Since it is non-sterile and operates as a standalone application or within a healthcare IT infrastructure, updates and maintenance are handled through software patches or version upgrades provided by Philips, rather than physical replacement or sterilization.
How is the IntelliVue GuardianSoftware regulated, and what does that imply for hospitals or healthcare providers?
The IntelliVue GuardianSoftware is authorized under FDA 510K clearance and MDR (Medical Device Regulation) compliance, classifying it as a Class IIb device. This means it has undergone regulatory scrutiny to ensure safety and performance, and hospitals or providers must ensure their IT infrastructure meets the software’s requirements for integration. The system also supports standardized UDI (Unique Device Identifier) traceability, which aids in regulatory adherence and inventory management.
Can the IntelliVue GuardianSoftware be used alongside other healthcare IT systems, and how does it integrate with existing workflows?
Yes, the IntelliVue GuardianSoftware is designed to operate as a standalone application or integrate within a larger healthcare IT infrastructure. Its modular nature allows it to connect with electronic health records (EHRs), picture archiving and communication systems (PACS), or other clinical tools, enabling seamless data sharing and workflow efficiency. This flexibility helps hospitals leverage existing systems while enhancing real-time patient monitoring and decision support.
What does the software’s non-sterile classification mean for clinical use, and are there any special handling requirements?
The non-sterile classification of the IntelliVue GuardianSoftware means it does not require sterilization before or after use, as it is not intended for direct contact with sterile body areas or invasive procedures. However, since it operates in clinical environments where patient data integrity is critical, healthcare providers should follow standard IT hygiene practices—such as regular software updates, secure access controls, and proper maintenance—to ensure reliability and data security.
Properties & raw data
Show properties, registry sources and raw records
Other properties (21)
- 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
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (3)
- EUDAMED 18f0b2e7-874a-4c48-9225-70733df3a301
- FDA UDI 9a9c140b-d23b-4fe7-9a6b-f2efaaff6b41
- FDA 510(k) K161767