| Primary Device ID | 00850005949411 |
| NIH Device Record Key | 8b048a69-f36b-453f-818b-4dd1df5593b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioButton At-Home Kit with Power Adaptor and Adhesives |
| Version Model Number | KIT-BBR-3763-5 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00850005949404 [Primary] |
| GS1 | 00850005949411 [Package] Contains: 00850005949404 Package: Master Carton (MC) [50 Units] In Commercial Distribution |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-24 |
| Device Publish Date | 2023-11-16 |
| 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) | 2024-05-09 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 |