Note: 00850005949299 (Model# BIOST06040) is equivalent to BBN-r (BBN v3) (01) 00850005949183 (Model# BIOST06040F), coming from different production batches and with a different model#. The…
Note: 00850005949299 (Model# BIOST06040) is equivalent to BBN-r (BBN v3) (01) 00850005949183 (Model# BIOST06040F), coming from different production batches and with a different model#. The intended use is identical to 00850005949183: The 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. P/N: BBR-B-NF-I-N
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (2), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for BioButton v3 (BBN-r, different batch) | Listed by | Biointellisense Inc., United States |
| FDA product code | DRG |
| Device type | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2910 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K191614 |
| Record published | 2023-09-05 |
| Record revised | 2023-11-30 (version 3) |
Specifications
Specifications | MRI safety | MR Unsafe |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Storage | Storage environment temperature 10 to 25 °C; Storage environment humidity 10 to 75 % RH |
| Packaging | Master carton (mc) of 195, inner carton of 12, master carton (mc) of 16 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.