Fever Garde
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Basic Information
- Brand Name
- Fever Garde
- Primary DI
- 08800132200413
- Version / Model
- HMT-100
- Company Name
- HuBDIC Co., Ltd.
- Labeler DUNS
- 688454128
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-13
- Public Version
- 1
- Public Version Date
- 2022-04-21
- Public Version Status
- New
- Public Device Record Key
- bdf0baef-11f6-44af-976b-2940bfea9912
Device Description
The Bluetooth Wearable Thermometer is an electronic thermometer using a sensor to measure right armpit temperature. Its operation is based on measuring the natural thermal radiation emanating from the armpit and the adjacent surfaces. Its software performs a calculation that factors in room temperature, and then a calculated temperature is displayed on the mobile device. Purpose of measuring body temperature is to check body condition by measuring correct temperature in important part of body and both measured room temperature and relative humidity are to show environmental conditions. In case of right armpit measurement, this product searches the highest temperature from the right armpit.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 08800132200413 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191978 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity