BioSticker™ System Offload Software

GUDID 00850005949046

Offload Software for the BioSticker System.

BIOINTELLISENSE, INC.

Electrocardiography telemetric monitoring system transmitter

• Primary Device ID: 00850005949046
• NIH Device Record Key: c9a76793-f366-4b78-a4a4-262c86da6f17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioSticker™ System Offload Software
• Version Model Number: SWDT10001-1.1.1
• Company DUNS: 116984478
• Company Name: BIOINTELLISENSE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00850005949046 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-11
• Device Publish Date: 2020-05-01

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