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510(k) Data Aggregation
K Number
K052751Device Name
VENTLINK SYSTEM
Manufacturer
MEDISERVE INFORMATION SYSTEMS, INC.
Date Cleared
2005-12-23
(84 days)
Product Code
MOD
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
MEDISERVE INFORMATION SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VentLink system is intended for use with specified or validated ventilator devices to obtain ventilator data and provide the user with the ability to display, store, print and otherwise process that data to other interfaced systems. VentLink is not connected directly to any patient nor does the VentLink device remotely control any connected ventilator device.
The VentLink system is intended for use in any clinical setting while interfaced to any specified or validated ventilator device. The VentLink system is intended to provide a secondary display of data received from an interfaced ventilator device to appropriately configured workstations and wireless laptop computers and to be made available to any interfaced hospital information system (HIS).
Device Description
The VentLink system is a device composed of MediServe Information Systems' proprietary software and various off-the-shelf hardware, operating system software and third-party proprietary software intended to be interfaced with specified or validated ventilator devices to allow authorized users to move ventilator patient data to wireless laptops and workstations configured with MediServe Information Systems' MediLinks data storage software. Additionally, the VentLink system allows users to move ventilator data to the user's hospital information system (HIS). It is intended to be used in an environmentally controlled hospital and hospital type environment.
The VentLink system software allows users to:
- Enable or disable automatic device data collection.
- Set a default data collection time interval.
- Specify how long unauthenticated data will be retained.
- Alert the user when data collection is paused.
After user review and validation of results received via the Ethernet the results are stored short-term on the VentLink system and transmitted to MediLinks for acceptance and storage.
Specified or validated ventilator devices are interfaced and added to the VentLink system through VentLink's devices' dictionary.
The VentLink system does not alter or change any patient data, but does allow the user to display the received patient data.
VentLink will function within a wide array of connectivity modules which allow VentLink to adapt to the evolving connectivity technology.
VentLink also has advanced device-management functionality.
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