BioButton Rechargeable Adhesives N/A

GUDID 10850005949234

Adhesive accessory packs for wearable devices

BIOINTELLISENSE, INC.

Basic skin adhesive tape

• Primary Device ID: 10850005949234
• NIH Device Record Key: f5a74b41-9586-4fae-8eb4-4e75433df6d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioButton Rechargeable Adhesives
• Version Model Number: ACCS-1-ST06-1-4
• Catalog Number: N/A
• Company DUNS: 116984478
• Company Name: BIOINTELLISENSE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005949237 [Primary]
GS1	10850005949234 [Package]; Contains: 00850005949237; Package: 50-pack Inner Carton [50 Units]; In Commercial Distribution
GS1	20850005949231 [Package]; Package: 6-box Master Carton [6 Units]; In Commercial Distribution
GS1	30850005949238 [Package]; Contains: 00850005949237; Package: 2-pack Inner Carton [2 Units]; In Commercial Distribution
GS1	40850005949235 [Package]; Contains: 30850005949238; Package: 100-mailer Master Ca [100 Units]; In Commercial Distribution

FDA Product Code

• KGX: Tape And Bandage, Adhesive

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: 2022-03-09
• Device Publish Date: 2022-03-01

Devices Manufactured by BIOINTELLISENSE, INC.

• 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