| 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 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 |
| KGX | Tape And Bandage, Adhesive |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-28 |
| Device Publish Date | 2022-07-20 |
| 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 |