FDA.reportPublic FDA data

WowGoHealth IR Ear Thermometer with Bluetooth GSH-BTS301

Primary DI
04719878123013
Brand
WowGoHealth IR Ear Thermometer with Bluetooth GSH-BTS301
Company
GOLDEN SMART HOME TECHNOLOGY CORP.
Model
GSH-BTS301
Device description
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.
Published
2019-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110559000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110559000AVITA INFRARED THEROMETER WITH BLUETOOTHAvita Corporation2012-01-06FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54719878123018PackageGS140In Commercial Distribution
04719878123013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5471987812301854719878123018
04719878123013047198781230134719878123013

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, earA hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal. In most cases it is intended to estimate the internal (core) temperature of the body by measurement of infrared radiation from within the auditory canal. It may claim to measure directly the infrared emissions from the tympanic membrane. An infrared ear thermometer usually displays values corrected by an offset of actual patient oral/rectal temperatures. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height54.3Millimeter
Length158.5Millimeter
Weight70Gram
Width44.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+88635770693service@goldensmarthome.com.tw

Regulatory Flags#

DUNS number
656002163
Device count
1
Kit
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719878121125WowGoHealth Blood Glucose Test Strips - GSH-BGM902 - 2*25GSH-BGM902 - 2*252019-07-04
04719878123518WowGoHealth Infrared Ear & Forehead Thermometer GSH-351GSH-3512023-03-28
04719878124027WowGoHealth Pulse Oximeter GSH601GSH601Orange2021-01-26
04719878124010WowGoHealth Pulse Oximeter GSH601GSH601Gray2020-07-09
04719878122313WowGoHealth Bluetooth Body Fat AnalyzerGSH231 (A3K)2021-05-24
14719878122310WowGoHealth Bluetooth Body Fat AnalyzerGSH231 (A3K)2021-05-24
04719878120036WowGoHealth Automatic Arm Bluetooth Blood Pressure MonitorGSH8622020-08-07
34719878120037WowGoHealth Automatic Arm Bluetooth Blood Pressure MonitorGSH8622020-08-07
04719878122023WowGoHealth Body Fat Analyzer GSH202-BGSH202-B2020-04-19
14719878122020WowGoHealth Body Fat Analyzer GSH202-BGSH202-B2020-04-19
04719878120029WowGoHealth Blood Pressure Monitor GSH885BGSH885B2019-05-17
34719878120020WowGoHealth Blood Pressure Monitor GSH885BGSH885B2019-05-17
04719878120012WowGoHealthBlood Pressure Monitor LS802-B2019-04-18
04719878121019WowGoHealth Blood Glucose Monitoring System GSH-BGM902GSH-BGM9022019-07-04
04719878121156WowGoHealth Control Solution - GSH-BGM902 - Level 1GSH-BGM902 - Level 12019-07-04

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