BioButton SKU# B2-ST03-02-0-00-GY

GUDID 10850005949104

The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data. The device is intended for use on users who are 18 years of age or older. The device does not output heart rate or respiratory rate measurements during periods of motion or activity. The device is not intended for use on critical care patients.

BIOINTELLISENSE, INC.

Wearable multiple physiological parameter recorder

• Primary Device ID: 10850005949104
• NIH Device Record Key: ba94a6bd-d778-426a-8f46-c4272fcade22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioButton
• Version Model Number: BIOST03020F
• Catalog Number: SKU# B2-ST03-02-0-00-GY
• Company DUNS: 116984478
• Company Name: BIOINTELLISENSE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005949107 [Primary]
GS1	10850005949104 [Package]; Contains: 00850005949107; Package: Master Carton [165 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191614

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-04-26
• Device Publish Date: 2020-11-09

Devices Manufactured by BIOINTELLISENSE, INC.

• 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
• 00850005949374 - BioButton At-Home Kit with Adhesives and BioButton: 2023-11-24 BioButton At-Home Kit with Adhesives and BioButton
• 00850005949398 - BioButton At-Home Kit: 2023-11-24 BioButton At-Home Kit
• 00850005949411 - BioButton At-Home Kit with Power Adaptor and Adhesives: 2023-11-24 BioButton At-Home Kit with Power Adaptor and Adhesives
• 10850005949227 - BioButton v3 (BBN-r, different batch, Individual Pack): 2023-10-06 Note: 00850005949220 (Model# BIOST06040) is equivalent to BBN-r (BBN v3) (01) 00850005949183 (Model# BIOST06040F), coming from d
• 00850005949299 - BioButton v3 (BBN-r, different batch): 2023-09-13 Note: 00850005949299 (Model# BIOST06040) is equivalent to BBN-r (BBN v3) (01) 00850005949183 (Model# BIOST06040F), coming from d