Identity
- Trade Name
- Xper Information Management System FDA UDI
- Generic Name
- Patient health record information system FDA UDI
- Device Name
- The information management system is intended for use under the direct supervision of a healthcare practitioner for acquiring, displaying, trending, storing and transmitting various types of data, such as physiologic/hemodynamic, clinical, medical image and other related data. The system is capable of processing/analyzing information, such as multi-channel ECG signals, 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. FDA UDI
- Model / Reference
- 2.3 FDA UDI
- Description
- The information management system is intended for use under the direct supervision of a healthcare practitioner for acquiring, displaying, trending, storing and transmitting various types of data, such as physiologic/hemodynamic, clinical, medical image and other related data. The system is capable of processing/analyzing information, such as multi-channel ECG signals, 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. FDA UDI
Identifiers
- Catalog Number
- 98960612322x FDA UDI
- Primary DI / UDI-DI
- 00884838085213 FDA UDI
- FDA Product Code
- DQK FDA UDI
- GMDN Term
- Patient health record information system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1425 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
Yes
FDA UDI
Category: Patient health record information system
Xper Information Management System by Philips Medical Systems Nederland B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient health record information system.
- Connect — LivaNova Deutschland GmbH · Class II
- Home Monitoring Service Center — BIOTRONIK SE & Co. KG · Class III
- Clinic Laptop — CANARY MEDICAL USA LLC · Class I
- Home Monitoring Service Center — BIOTRONIK SE & Co. KG · Class III
- ELI Edit — MORTARA INSTRUMENT, INC. · Class II
- ESSENZ — LivaNova Deutschland GmbH · Class II
- Datapad — LivaNova Deutschland GmbH · Class II
- ELI Edit — MORTARA INSTRUMENT, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips Medical Systems Nederland B.V.
Sources (1)
- FDA UDI d23ebb3b-4fac-413e-be1f-94b9fd37f523 35 fields · synced Sep 18, 2026