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 ID: 00884838100084
• NIH Device Record Key: ccd43c7a-5dc2-4318-8292-0f5779efe266
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xper Information Management System
• Version Model Number: 5
• Catalog Number: 830230
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(999)999-9999
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838100084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101571

FDA Product Code

• DQK: Computer, diagnostic, programmable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-13
• Device Publish Date: 2020-05-05

On-Brand Devices [Xper Information Management System]

• 00884838087330: The Xper Information Management System is used for acquiring, displaying, trending, storing and
• 00884838085213: The information management system is intended for use under the direct supervision of a healthca
• 00884838081291: 2.2
• 00884838070721: 2.1
• 00884838070691: 1.5
• 00884838091771: The Xper Information Management System is used for acquiring, displaying, trending, storing and
• 00884838098985: The information management system is intended for use under the direct supervision of a healthca
• 00884838100084: The Xper Information Management System is used for acquiring, displaying, trending, storing and
• 00884838105034: The Information Management System is a software to acquire, display, trend, store, and transmit