Fever Garde

GUDID 08800132200413

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.

HuBDIC Co., Ltd.

Wireless patient thermometer, reusable
Primary Device ID08800132200413
NIH Device Record Keybdf0baef-11f6-44af-976b-2940bfea9912
Commercial Distribution StatusIn Commercial Distribution
Brand NameFever Garde
Version Model NumberHMT-100
Company DUNS688454128
Company NameHuBDIC Co., Ltd.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108800132200413 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-21
Device Publish Date2022-04-13

Devices Manufactured by HuBDIC Co., Ltd.

08800132210160 - HuBDIC Nasal Aspirator2022-09-15
08800132210177 - HuBDIC Nasal Aspirator2022-09-15
08800132200161 - THERMOFINDER2022-04-21 The Non-Contact Infrared Thermometer is an electronic thermometer using an infrared sensor (thermopile) to measure forehead temp
08800132200178 - THERMOFINDER2022-04-21 The Non-Contact Infrared Thermometer is an electronic thermometer using an infrared sensor (thermopile) to measure forehead temp
08800132200239 - Thermofinder S2022-04-21 The Non-Contact Infrared Thermometer is an electronic thermometer using an infrared sensor (thermopile) to measure forehead temp
08800132200246 - Thermofinder S2022-04-21 The Non-Contact Infrared Thermometer is an electronic thermometer using an infrared sensor (thermopile) to measure forehead temp
08800132200413 - Fever Garde2022-04-21The 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.
08800132200413 - Fever Garde2022-04-21 The Bluetooth Wearable Thermometer is an electronic thermometer using a sensor to measure right armpit temperature. Its operatio

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.