DEVICE: Visensia (05060457930010)

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Device Identifier (DI) Information

Visensia
3
011-0124
OBS MEDICAL LIMITED
05060457930010
GS1
1
Visensia® software is a computerized analysis software program designed as an adjunct to standard patient monitors or medical information systems. It operates by forming an aggregate score of patient status based on five vital signs; heart rate; respiratory rate; temperature; noninvasive blood pressure and arterial oxygen saturation. The aggregate score, the Visensia® Index, is displayed on a scale of 0-5, with 0 representing the normal end of the scale and 5 representing extreme physiological deterioration. An audible and visual alert is provided when the Visensia® index exceeds a threshold value for a period of time. The Visensia® Index is calculated whenever new data is received.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Clinical data collection/management information system application software An application software program, routines, and/or algorithms designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information management. It is installed to provide transportation of discrete, waveform and infusion data from medical devices, as well as laboratory data, into an electronic medical record (EMR) and/or an application for viewing and verification by a clinician. The data can be aggregated for, e.g., patient treatment summary calculations, ordering of infusion solutions/drugs, and laboratory sample tests.
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FDA Product Code

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Product Code Product Code Name
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
April 05, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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Yes
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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