Sickbay Clinical Platform

Primary DI
B693SICKBAY0301200
Brand
Sickbay Clinical Platform
Company
MEDICAL INFORMATICS CORP.
Model
3.1.20.
Device description
Sickbay Clinical Platform is a software product that is intended to run on hospital servers on a hospital’s secure network. It gathers and stores all the physiological sensor data from patients admitted to the ER or ICU and is capable of re-displaying all the physiological sensor data in real-time when gathered or at any later time. The Sickbay Clinical Platform can be thought of as three distinct subsystems working together. The first subsystem is called the Sickbay Informatics server. This component does most of the work involving acquisition and archiving physiological data, executing data processing and data management functionality, and serving data on request to clients. The second component of sickbay is a database. The database is used to organize all of the relationships between data on the sickbay system. The third component of the Sickbay Clinical Platform is a web-server used for data visualization.
Published
2018-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143304000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143304000Sickbay Clinical PlatformMedical Informatics Corp2015-05-26MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B693SICKBAY0301200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment clinical data interfacing softwareAn application software 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 intended to transfer waveform, infusion data, laboratory data from medical devices/lab equipment into an electronic medical record (EMR) 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; it is not primarily intended to manage diagnostic/patient images.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014363314
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B693SICKBAY034600Sickbay Clinical Platform3.46.0.0.2026-03-04
B693SICKBAY034500Sickbay Clinical Platform3.45.0.02025-07-28
B693SICKBAY034400Sickbay Clinical Platform3.44.0.02025-04-14
B693SICKBAY034300Sickbay Clinical Platform3.43.0.02024-10-09
B693SICKBAY034200Sickbay Clinical Platform3.42.0.02024-06-07
B693SICKBAY034100Sickbay Clinical Platform3.41.0.02024-02-23
B693SICKBAY034000Sickbay Clinical Platform3.40.0.02023-11-13
B693SICKBAY0301240Sickbay Clinical Platform3.1.242019-09-30
B693SICKBAY0301210Sickbay Clinical Platform3.1.212019-03-08

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