Xper Information Management System 830230

GUDID 00884838100084

The Xper Information Management System is used for acquiring, displaying, trending, storing and transmitting various types of data such as physiologic/hemodynamic, clinical, medical image and other related data. Its users, responsible to interpret the data provided, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The system is capable of processing/analyzing information such as multi-channel ECG signals, displaying a graphical ST segment map and performing other data management functions such as creating reports. Data may be acquired from and/or sent to other devices such as physiological monitoring systems, information management systems, image acquisition/storage devices and other medical devices. The Xper Information Management System also provides optional ancillary functions, such as scheduling, inventory control, patient billing, statistical reporting, and other non-clinical modules. Users of the ancillary functions may be health care providers, but may also be nonclinical users authorized by the facility.

Philips Medical Systems Nederland B.V.

Patient health record information system
Primary Device ID00884838100084
NIH Device Record Keyccd43c7a-5dc2-4318-8292-0f5779efe266
Commercial Distribution StatusIn Commercial Distribution
Brand NameXper Information Management System
Version Model Number5
Catalog Number830230
Company DUNS413819707
Company NamePhilips Medical Systems Nederland B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(999)999-9999
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Device Identifiers

Device Issuing AgencyDevice ID
GS100884838100084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQKComputer, diagnostic, programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-13
Device Publish Date2020-05-05

On-Brand Devices [Xper Information Management System]

00884838087330The Xper Information Management System is used for acquiring, displaying, trending, storing and
00884838085213The information management system is intended for use under the direct supervision of a healthca
008848380812912.2
008848380707212.1
008848380706911.5
00884838091771The Xper Information Management System is used for acquiring, displaying, trending, storing and
00884838098985The information management system is intended for use under the direct supervision of a healthca
00884838100084The Xper Information Management System is used for acquiring, displaying, trending, storing and
00884838105034The Information Management System is a software to acquire, display, trend, store, and transmit

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