| Primary Device ID | 10850005949555 |
| NIH Device Record Key | 750041c9-7d9f-4fcb-ab74-19714198d4df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioButton (Reprocessed) |
| Version Model Number | BBR-B-I-R |
| Catalog Number | n/a |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1 888-908-8804 |
| support@biointellisense.com | |
| Phone | +1 888-908-8804 |
| support@biointellisense.com | |
| Phone | +1 888-908-8804 |
| support@biointellisense.com | |
| Phone | +1 888-908-8804 |
| support@biointellisense.com | |
| Phone | +1 888-908-8804 |
| support@biointellisense.com | |
| Phone | +1 888-908-8804 |
| support@biointellisense.com | |
| Phone | +1 888-908-8804 |
| support@biointellisense.com | |
| Phone | +1 888-908-8804 |
| support@biointellisense.com | |
| Phone | +1 888-908-8804 |
| support@biointellisense.com | |
| Phone | +1 888-908-8804 |
| support@biointellisense.com | |
| Phone | +1 888-908-8804 |
| support@biointellisense.com | |
| Phone | +1 888-908-8804 |
| support@biointellisense.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850005949558 [Primary] |
| GS1 | 10850005949555 [Package] Contains: 00850005949558 Package: Box (12 Count) [12 Units] In Commercial Distribution |
| GS1 | 20850005949552 [Package] Package: Master Carton [16 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 | 2025-02-27 |
| Device Publish Date | 2025-02-19 |
| 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) | 2025-02-27The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data. The device is intended for use on users who are 18 years of age or older. The device does not output heart rate or respiratory rate measurements during periods of motion or activity. The device is not intended for use on critical care patients. Note: this model is reprocessed device. |
| 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 |