BioButton Rechargeable Adhesives (ADD-HT) N/A

GUDID 10850005949241

Adhesive accessory packs for wearable devices - 5 pcs, ADD, HT; SKU: ADH-AC1-BBR-5-1-1-10

BIOINTELLISENSE, INC.

Dressing-fixation skin adhesive tape, non-silicone

• Primary Device ID: 10850005949241
• NIH Device Record Key: cde0eba4-a345-46e8-8da1-9bdd06282fd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioButton Rechargeable Adhesives (ADD-HT)
• Version Model Number: ADH-AC1-BBR-5-1-1-10
• 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	00850005949244 [Primary]
GS1	00850005949435 [Package]; Contains: 00850005949244; Package: Box 12x5 [12 Units]; In Commercial Distribution
GS1	10850005949241 [Package]; Contains: 00850005949244; Package: Inner Carton - 50x5 [50 Units]; Discontinued: 2022-07-20; Not in Commercial Distribution
GS1	20850005949248 [Package]; Contains: 00850005949244; Package: Inner Carton - 2x5 [2 Units]; Discontinued: 2022-07-20; Not in Commercial Distribution
GS1	20850005949439 [Package]; Contains: 00850005949435; Package: Inner Carton 5x12x5 [5 Units]; In Commercial Distribution
GS1	30850005949245 [Package]; Package: MC-6x50x5 [6 Units]; Discontinued: 2022-07-20; Not in Commercial Distribution
GS1	30850005949436 [Package]; Contains: 20850005949439; Package: Master Carton 6x5x12 [6 Units]; In Commercial Distribution
GS1	40850005949242 [Package]; Contains: 20850005949248; Package: MC-100x2x5 [100 Units]; Discontinued: 2022-07-20; Not 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: 2022-07-28
• Device Publish Date: 2022-07-20

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