RhythmAnalytics

GUDID 08885018690014

Biofourmis, Inc

Cardiac electrophysiology application software

• Primary Device ID: 08885018690014
• NIH Device Record Key: 33800067-2897-401f-9e25-11babfeea5ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RhythmAnalytics
• Version Model Number: 1.1
• 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	08885018690014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182344

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

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