FDA.reportPublic FDA data

Rexall

Primary DI
06931562700623
Brand
Rexall
Company
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.
Model
ET-100B
Device description
intended to measure human body temperature in ear canal
Published
2022-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K172870000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172870000Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100JHangzhou Hua'An Medical&Health Instruments Co.,Ltd2018-02-13FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06931562700623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06931562700623069315627006236931562700623

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544611767
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06931562703433MY MEDICDT-01A2026-05-15
06931562703402IIFDT-11F2026-04-15
06931562703419IIFMB-300C2026-04-15
06931562703426IIFDT-K11E2026-04-15
06931562703006IIFMW-300C2025-12-23
06931562702719JASUNDT-K111I2025-07-24
06931562702726JASUNDT-K111J2025-07-24
06931562701323RexallFT-100B2022-06-17
06931562701637IIFDT-01D2021-06-03
06931562701477femometerDT-01D2020-09-08
06931562700883JASUNFT-100D2017-09-20
06931562701989IIFDT-101B2022-10-10
06931562701439RexallDT-01D2022-06-17
06931562701446RexallDT-101B2022-06-17
06931562701972RexallDT-Y111D2022-06-17
06931562701712IIFDT-111B2022-01-10
06931562701668Marathon HealthDT-111D2021-12-16
16931562700637ESSEFT1042016-10-11
16931562700644ESSEFT5162016-10-11
16931562700712ESSEFT1042016-10-25

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Primary DI, Brand, Company table
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00198953002186Carescape Dock F0GE Healthcare Finland OyFLL2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyFLL2026-10-04
00749756389181DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
00749756389204DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
06944413835153Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
00885403523437HemoSphere AltaBecton, Dickinson And CompanyFLL2026-08-06
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06970289030859foreverlittleHetaida Technology Co., LtdFLL2026-07-28
06953825911638ZKZOShenzhen Urion Technology Co., LtdFLL2026-07-23
B353UB25511UbiqVue MultiparameterLifesignals, Inc.FLL2026-07-20
06972040114334N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040114341N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040115522N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06931973457093CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06931973457109CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06970758502641CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06970758508865CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
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00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.FLL2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28