Biovitals Analytics Engine

GUDID 08885018690021

Biofourmis, Inc

Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver

• Primary Device ID: 08885018690021
• NIH Device Record Key: 7aceb156-be10-468f-b7cd-756e478a0d0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biovitals Analytics Engine
• Version Model Number: 2.0
• Company DUNS: 117164663
• Company Name: Biofourmis, Inc
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08885018690021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183282

FDA Product Code

• PLB: Multivariate Vital Signs Index

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: 2022-11-07
• Device Publish Date: 2022-10-28

Devices Manufactured by Biofourmis, Inc

• 08885018690014 - RhythmAnalytics: 2022-11-07
• 08885018690021 - Biovitals Analytics Engine: 2022-11-07
• 08885018690021 - Biovitals Analytics Engine: 2022-11-07