BioButton Adhesive V2 (ADH-CS) N/A

GUDID 00850005949534

BioButton Cold Seal Adhesive V2 (ADH-CS)

BIOINTELLISENSE, INC.

Dressing-fixation skin adhesive tape, non-silicone

• Primary Device ID: 00850005949534
• NIH Device Record Key: 10538fee-8fe6-458e-9ac7-6119479517d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioButton Adhesive V2 (ADH-CS)
• Version Model Number: ADH-CS-10771
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005949510 [Package]; Contains: 00850005949541; Package: ADH-CS-60-10813 [60 Units]; In Commercial Distribution
GS1	00850005949527 [Package]; Contains: 00850005949541; Package: ADH-CS-7-11264 [7 Units]; In Commercial Distribution
GS1	00850005949534 [Package]; Contains: 00850005949541; Package: ADH-CS-30-10813 [30 Units]; In Commercial Distribution
GS1	00850005949541 [Primary]
GS1	10850005949517 [Package]; Contains: 00850005949510; Package: ADH-CS-60B-10813 [5 Units]; In Commercial Distribution
GS1	10850005949524 [Package]; Contains: 00850005949527; Package: ADH-CS-7M-11264 [100 Units]; In Commercial Distribution
GS1	20850005949514 [Package]; Contains: 10850005949517; Package: ADH-CS-60M-10813 [6 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: 2024-05-09
• Device Publish Date: 2024-05-01

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): 2024-05-09BioButton Cold Seal Adhesive V2 (ADH-CS)
• 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