BioButton At-Home Kit with Power Adaptor

GUDID 00850005949336

BioButton At-Home Kit with Power Adaptor

BIOINTELLISENSE, INC.

Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable

• Primary Device ID: 00850005949336
• NIH Device Record Key: db45fb3c-9ce7-4d71-9968-71cb2dd4604c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioButton At-Home Kit with Power Adaptor
• Version Model Number: KIT-BBR-3763-1
• Company DUNS: 116984478
• Company Name: BIOINTELLISENSE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• 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	00850005949312 [Primary]
GS1	00850005949336 [Package]; Contains: 00850005949312; Package: Master Carton (MC) [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212957

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: 2023-11-24
• Device Publish Date: 2023-11-16

Devices Manufactured by BIOINTELLISENSE, INC.

• 00850005949336 - BioButton At-Home Kit with Power Adaptor: 2023-11-24BioButton At-Home Kit with Power Adaptor
• 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