DEVICE: Xper Information Management System (00884838100084)

Device Identifier (DI) Information

Xper Information Management System
5
In Commercial Distribution
830230
Philips Medical Systems Nederland B.V.
00884838100084
GS1

1
413819707 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
38473 Patient health record information system
A dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. The system typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DQK Computer, diagnostic, programmable
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

ccd43c7a-5dc2-4318-8292-0f5779efe266
September 26, 2023
3
May 05, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(999)999-9999
xx@xx.xx
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