BioButton Rechargeable Device, Multi-Patient
Basic Information
- Brand Name
- BioButton Rechargeable Device, Multi-Patient
- Primary DI
- 00850005949442
- Version / Model
- BBRM-B-I-N
- Catalog Number
- N/A
- Company Name
- BIOINTELLISENSE, INC.
- Labeler DUNS
- 116984478
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-11
- Public Version
- 1
- Public Version Date
- 2025-02-19
- Public Version Status
- New
- Public Device Record Key
- d8b87a45-97c5-4a72-9603-6db993751889
Device Description
The BioButton System (Multi-patient) is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This could include heart rate, respiratory rate, skin temperature, and other data such as activity level, body position, sleep, and step and gait analysis. Data are securely transmitted via wireless connection for storage, review, analysis, and display. The Device can include the ability to display data and notify healthcare professionals when physiological data fall outside clinician-specified parameters. The data from the Device are intended as an aid to diagnosis, disease management, and treatment. The Device is intended for use on patients who are 18 years of age or older. The Device is not intended to output physiological measurements while the patient undergoes significant motion or is active. The Device is not intended for critical care. This Device is cleared in K241101 to be reprocessed and reused.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Cardiovascular | 870.2910 | 2 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12391 | Wearable multiple physiological parameter recorder, reusable | An electrically-powered wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiogram (ECG), haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a smart device or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850005949449 | GS1 | 12count inner carton | 12 | In Commercial Distribution | |
| Primary | 00850005949442 | GS1 | ||||
| Package | 20850005949446 | GS1 | 16pack master carton | 16 | In Commercial Distribution |
Customer Contacts
- Phone
- +1 888-908-8804
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241101 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 25 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 75 Percent (%) Relative Humidity