BioDashboard N/A

GUDID 00850005949466

BioDashboard, as part of the FDA-cleared BioButton System, is intended to display and visualize physiological and medical data and log assessments. The Device displays data and notifies healthcare professionals when physiological data fall outside clinician specified parameters. The data from the Device are intended as an aid to diagnosis, diseases management, and treatment. The Device has the ability to allow the clinician to configure the parameters for notifications. Healthcare professionals are the intended operators of this device. The Device is intended for use on patients who are 18 years of age or older. The Device is not intended for critical care.

BIOINTELLISENSE, INC.

Clinical management support software

• Primary Device ID: 00850005949466
• NIH Device Record Key: 333e3cdc-2d31-48c4-948b-5f1a3f88b6fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioDashboard
• Version Model Number: SW-BDB
• Catalog Number: N/A
• Company DUNS: 116984478
• Company Name: BIOINTELLISENSE, 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 888-908-8804
• Email: support@biointellisense.com
• Phone: +1 888-908-8804
• Email: support@biointellisense.com
• Phone: +1 888-908-8804
• Email: support@biointellisense.com
• Phone: +1 888-908-8804
• Email: support@biointellisense.com
• Phone: +1 888-908-8804
• Email: support@biointellisense.com
• Phone: +1 888-908-8804
• Email: support@biointellisense.com
• Phone: +1 888-908-8804
• Email: support@biointellisense.com
• Phone: +1 888-908-8804
• Email: support@biointellisense.com
• Phone: +1 888-908-8804
• Email: support@biointellisense.com
• Phone: +1 888-908-8804
• Email: support@biointellisense.com
• Phone: +1 888-908-8804
• Email: support@biointellisense.com
• Phone: +1 888-908-8804
• Email: support@biointellisense.com
• Phone: +1 888-908-8804
• Email: support@biointellisense.com
• Phone: +1 888-908-8804
• Email: support@biointellisense.com
• Phone: +1 888-908-8804
• Email: support@biointellisense.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005949466 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241101

FDA Product Code

• DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

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: 2025-03-10
• Device Publish Date: 2025-02-28

Devices Manufactured by BIOINTELLISENSE, INC.

• 00850005949466 - BioDashboard: 2025-03-10BioDashboard, as part of the FDA-cleared BioButton System, is intended to display and visualize physiological and medical data and log assessments. The Device displays data and notifies healthcare professionals when physiological data fall outside clinician specified parameters. The data from the Device are intended as an aid to diagnosis, diseases management, and treatment. The Device has the ability to allow the clinician to configure the parameters for notifications. Healthcare professionals are the intended operators of this device. The Device is intended for use on patients who are 18 years of age or older. The Device is not intended for critical care.
• 00850005949466 - BioDashboard: 2025-03-10 BioDashboard, as part of the FDA-cleared BioButton System, is intended to display and visualize physiological and medical data a
• 10850005949555 - BioButton (Reprocessed): 2025-02-27 The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, res
• 10850005949562 - BioButton (Reprocessed, NF Version): 2025-02-27 The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, res
• 10850005949593 - BioButton Charging Station: 2025-02-27 The BioButton Charging Station is intended to be used by trained professionals to charge multiple compatible rechargeable wearab
• 10850005949449 - BioButton Rechargeable Device, Multi-Patient: 2025-02-19 The BioButton System (Multi-patient) is a remote monitoring wearable device intended for continuous collection of physiological
• 00850005949534 - BioButton Adhesive V2 (ADH-CS): 2024-05-09 BioButton Cold Seal Adhesive V2 (ADH-CS)
• 00850005949336 - BioButton At-Home Kit with Power Adaptor: 2023-11-24 BioButton At-Home Kit with Power Adaptor
• 00850005949350 - BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton: 2023-11-24 BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton