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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Specimen Gate® Laboratory is a modular laboratory information management system intended for use as a calculator/data processing software for the storage, retrieval, and processing of laboratory data in newborn screening laboratories.
Wallac Oy
5002-0180
In Commercial Distribution

  • 06438147153312 ()
5002-0180

  • Clinical laboratory information system
Specimen Gate® PatientCare™ is intended for management of the follow-up workflow of a screening system.
Wallac Oy
5002-0130
In Commercial Distribution

  • 06438147153275 ()
5002-0130

  • Clinical laboratory information system
The MSMS Workstation is intended for use as a calculator/data processing software for the storage, retrieval, and processing of mass spectrometry data.
Wallac Oy
5002-0540
In Commercial Distribution

  • 06438147352401 ()
5002-0540

  • Clinical laboratory information system
No Description
Philips Medical Systems Nederland B.V.
2.1
In Commercial Distribution

  • 00884838070721 ()
453564530681

  • Patient health record information system
No Description
Philips Medical Systems Nederland B.V.
1.5
In Commercial Distribution

  • 00884838070691 ()
453564495001

  • Patient health record information system
The Information Management System is a software to acquire, display, trend, store, and transmit physiologic, hemodynamic, clinical, medical images, and other related data.
Philips Medical Systems Nederland B.V.
6
In Commercial Distribution

  • 00884838105034 ()
830230

  • Patient health record information system
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.
5
In Commercial Distribution

  • 00884838100084 ()
830230

  • Patient health record information system
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. The system is indicated for use in the following areas: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and surrounding areas where access to the information is needed. The system consists of modules and may be entirely a software offering or a hardware/software offering. It is intended for use on standard computer systems and does not require proprietary hardware. The solution is available as a single module or combination of modules, or may function as a standalone system. The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet, or may function as a standalone device.
Philips Medical Systems Nederland B.V.
2.6
In Commercial Distribution

  • 00884838098985 ()
98960612834x

  • Patient health record information system
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.
2.5
In Commercial Distribution

  • 00884838091771 ()
98960612665x

  • Patient health record information system
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.
2.4
In Commercial Distribution

  • 00884838087330 ()
98960612482x

  • Patient health record information system
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