BioButton Rechargeable Adhesives N/A

GUDID 10850005949234

Adhesive accessory packs for wearable devices

BIOINTELLISENSE, INC.

Basic skin adhesive tape Basic skin adhesive tape Basic skin adhesive tape Basic skin adhesive tape Basic skin adhesive tape Basic skin adhesive tape Basic skin adhesive tape Basic skin adhesive tape Basic skin adhesive tape Basic skin adhesive tape Basic skin adhesive tape Basic skin adhesive tape Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone

• 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.

• 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
• 00850005949282 - BioButton (In Bulk Packaging): 2023-07-11 The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, res