FDA UDI
In Commercial Distribution
🇺🇸 United States
BioButton At-Home Kit
DI: 00850005949381
·
Model: KIT-BBR-3763-2
·
BIOINTELLISENSE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BioButton At-Home Kit
- Primary DI
- 00850005949381
- Version / Model
- KIT-BBR-3763-2
- Company Name
- BIOINTELLISENSE, INC.
- Labeler DUNS
- 116984478
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-16
- Public Version
- 1
- Public Version Date
- 2023-11-24
- Public Version Status
- New
- Public Device Record Key
- aa3339e6-aa2e-4f51-a968-1458e1512145
Device Description
BioButton At-Home Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
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 | 00850005949398 | GS1 | Master Carton (MC) | 50 | In Commercial Distribution | |
| Primary | 00850005949381 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212957 | 000 |