IntelliVue GuardianSoftware

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…

Registry build 21.09.26

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.

1manufacturer
3catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code DXJ
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77

Record

Regulatory record for IntelliVue GuardianSoftware
Listed by Philips Medizin Systeme Böblingen GmbH, Germany
FDA product code DXJ
Device type Display, Cathode-Ray Tube, Medical
Device class Class 2
Regulation 21 CFR 870.2450
Record published 2018-01-17
Record revised 2023-07-28 (version 8)

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for IntelliVue GuardianSoftware
Catalogue number Size Status
IntelliVue GuardianSoftware In distribution
E In distribution
IntelliVue GuardianSoftware In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Nexxis OR Barco, Inc 85
Nexxis Barco, Inc 81
Merit Medical® Merit Medical Systems, Inc. 67
Vital Signs Carefusion Finland 320 Oy 17
Excite™ Merit Medical Systems, Inc. 14
Vital Signs™ AirLife Finland Oy 12
VantageView™ St. Jude Medical 11
Medline Industries, Inc. Medline Industries, Inc. 7
Barco Barco, Inc 4
Datapad LivaNova Deutschland GmbH 3
Connect LivaNova Deutschland GmbH 2
Display, Cathode-Ray Tube, Medical Philips Medical Systems Hsg 2

Showing 12 of 24. All products under Display, Cathode-Ray Tube, Medical

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer