WowGoHealth IR Ear Thermometer with Bluetooth GSH-BTS301

GUDID 04719878123013

The WowGoHealth IR Ear Thermometer with Bluetooth (Model GSH-BTS301) is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.

GOLDEN SMART HOME TECHNOLOGY CORP.

Infrared patient thermometer, ear
Primary Device ID04719878123013
NIH Device Record Key5c1b1fee-4ed8-4959-b6a6-28802963cd8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameWowGoHealth IR Ear Thermometer with Bluetooth GSH-BTS301
Version Model NumberGSH-BTS301
Company DUNS656002163
Company NameGOLDEN SMART HOME TECHNOLOGY CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+88635770693
Emailservice@goldensmarthome.com.tw

Device Dimensions

Height54.3 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104719878123013 [Primary]
GS154719878123018 [Package]
Package: Carton [40 Units]
In Commercial Distribution

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 Date2019-07-22
Device Publish Date2019-07-12

Devices Manufactured by GOLDEN SMART HOME TECHNOLOGY CORP.

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34719878120037 - WowGoHealth Automatic Arm Bluetooth Blood Pressure Monitor2020-08-17 Automatic Arm Bluetooth Blood Pressure Monitor GSH862, intended to measure the systolic and diastolic blood pressure and pulse r
04719878124010 - WowGoHealth Pulse Oximeter GSH6012020-07-17 The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxygen saturation and pulse rate for adu
14719878122020 - WowGoHealth Body Fat Analyzer GSH202-B2020-04-27 The Body Fat Analyzer measures weight and estimate BMI and calories, and uses bio-electrical impedance analysis (BIA) technology
34719878120020 - WowGoHealth Blood Pressure Monitor GSH885B2019-11-08 The WowGoHealth Blood Pressure Monitor GSH885B is digital monitors intended for use in measuring blood pressure and heartbeat ra
04719878120012 - WowGoHealth2019-11-08 The Blood Pressure Monitor LS802-B is digital monitor intended for use in measuring blood pressure and heartbeat rate in adult p

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