Sickbay Clinical Platform

GUDID B693SICKBAY0301240

Sickbay Clinical Platform is a software product that is intended to run 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 data in real-time when gathered or at a later time.

MEDICAL INFORMATICS CORP.

Medical equipment clinical data interfacing software

• Primary Device ID: B693SICKBAY0301240
• NIH Device Record Key: 905e54ad-ce2d-49ad-811d-260ee2594415
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sickbay Clinical Platform
• Version Model Number: 3.1.24
• Company DUNS: 014363314
• Company Name: MEDICAL INFORMATICS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B693SICKBAY0301240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143304

FDA Product Code

• MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-08
• Device Publish Date: 2019-09-30

On-Brand Devices [Sickbay Clinical Platform]

• B693SICKBAY0301210: Sickbay Clinical Platform is a software product that is intended to run on a hospital's secure n
• B693SICKBAY0301200: Sickbay Clinical Platform is a software product that is intended to run on hospital servers on a
• B693SICKBAY0301240: Sickbay Clinical Platform is a software product that is intended to run on a hospital's secure n
• B693SICKBAY034000: Sickbay Clinical Platform is a software product that is intended to run on a hospital's secure n
• B693SICKBAY034100: Sickbay Clinical Platform is a software product that is intended to run on a hospital's secure n
• B693SICKBAY034200: Sickbay Clinical Platform is a software product that is intended to run on a hospital's secure n
• B693SICKBAY034300: Sickbay Clinical Platform is a software product that is intended to run on a hospital's secure n