FDA UDI
In Commercial Distribution
🇺🇸 United States
Enfasmart feversense Continuous monitoring thermometer
DI: 00865064000164
·
Model: VV220
·
VIVALNK, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Enfasmart feversense Continuous monitoring thermometer
- Primary DI
- 00865064000164
- Version / Model
- VV220
- Company Name
- VIVALNK, INC.
- Labeler DUNS
- 013311479
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-30
- Public Version
- 2
- Public Version Date
- 2020-11-16
- Public Version Status
- Update
- Public Device Record Key
- f95630e7-d463-4a63-9007-f4bccc20358a
Device Description
The wireless Enfasmart FeverSense Continuous Monitoring Thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62450 | Wireless patient thermometer, reusable | A wearable, battery-powered, electronic device intended to continuously measure body temperature and wirelessly transmit data to a computing device, typically a smartphone or tablet with dedicated software, for recording and data display; it is typically used to monitor temperature during daily activities and sleep. It is in the form of an adhesive patch designed to be placed on the skin (typically in/near the armpit); a charging case and software may be included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00865064000164 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 104 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 104 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal