FDA UDI
In Commercial Distribution
🇺🇸 United States
BodiMetrics
DI: 06934440100713
·
Model: VitalsRX Health Monitor
·
Shenzhen Viatom Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BodiMetrics
- Primary DI
- 06934440100713
- Version / Model
- VitalsRX Health Monitor
- Company Name
- Shenzhen Viatom Technology Co., Ltd.
- Labeler DUNS
- 421357243
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-23
- Public Version
- 4
- Public Version Date
- 2022-10-10
- Public Version Status
- Update
- Public Device Record Key
- e327f993-e9f5-4d88-bba2-d3e1db7c3037
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48041 | Multiple physiological parameter spot-check system, home-use | An electrically-powered device assembly designed for use in the home to spot-check (user-initiated) measure and display multiple patient physiological parameters [e.g., blood pressure, blood glucose, pulse rate, temperature, haemoglobin oxygen saturation (SpO2), and possibly calculate mean arterial pressure (MAP)]. It typically includes a main unit with a visual display intended to process/store the data, and physiological measuring components (e.g., thermometer, blood pressure cuff, blood glucose meter); it may additionally allow the data to be communicated with a healthcare professional. It may be used in a healthcare facility and in the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06934440100713 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150869 | 000 |