Identity
- Trade Name
- IntelliVue GuardianSoftware FDA UDI
- Generic Name
- Medical equipment clinical data interfacing software FDA UDI
- Device Name
- IntelliVue GuardianSoftware is a software-only product. It is the core of the Guardian General Care Solution, which provides fully customizable workflow support for automated vital signs taking, early warning scoring, patient deteroration detection, caregiver notification and care escalation for medical/surgical care, ED waiting/triage and other general care areas. It also mediates the data flow between the devices and hospital systems. Guardian Software license options listed enable desired features and capabilities for specified number of patients, clients, selected measurement technologies as well as required connectivity to hospital systems. FDA UDI
- Model / Reference
- IntelliVue GuardianSoftware FDA UDI
- Description
- IntelliVue GuardianSoftware is a software-only product. It is the core of the Guardian General Care Solution, which provides fully customizable workflow support for automated vital signs taking, early warning scoring, patient deteroration detection, caregiver notification and care escalation for medical/surgical care, ED waiting/triage and other general care areas. It also mediates the data flow between the devices and hospital systems. Guardian Software license options listed enable desired features and capabilities for specified number of patients, clients, selected measurement technologies as well as required connectivity to hospital systems. FDA UDI
Identifiers
- Catalog Number
- 866009 FDA UDI
- Primary DI / UDI-DI
- 00884838081925 FDA UDI
- FDA Product Code
- DXJ FDA UDI
- GMDN Term
- Medical equipment clinical data interfacing software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Medical equipment clinical data interfacing software
IntelliVue GuardianSoftware by Philips Medizin Systeme Böblingen GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
Sources (1)
- FDA UDI 3fc3ae23-a28b-4ca3-b7e2-0304a63b9ee8 35 fields · synced May 30, 2026