FDA.reportPublic FDA data

Finicare

Primary DI
06971522820138
Brand
Finicare
Company
Shenzhen Finicare Co., Ltd
Model
FC-IR1012
Published
2019-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K181215000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181215000Infrared ThermometerShenzhen Finicare Co., Ltd.2019-01-02FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971522820138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971522820138069715228201386971522820138

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, ear/skinA hand-held, battery-powered, electronic instrument designed to measure: 1) the temperature of a patient's ear canal, typically to estimate the internal (core) temperature; and 2) the temperature of a site on the skin (e.g., axilla, forehead), by measurement of body infrared emissions. It typically includes both a skin-surface tip and an intra-aural tip. This device is intended for use in the home or healthcare facility. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544584610
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971522820916FinicareFC-BP1072026-05-06
06971522820923FinicareFC-BP1232026-05-06
06971522820930FinicareFC-BP1252026-05-06
06971522820947FinicareFC-BP1262026-05-06
06971522820954FinicareFC-BP1272026-05-06
06971522820961FinicareFC-BP1162026-05-06
06971522821487ZOMEEFC-BP1202026-04-21
06971522821494ZOMEEFC-BP1202026-04-21
06971522821333One Step®FC-BP1302026-04-01
06971522821005SimpliCareFC-IR2062025-12-04
06971522820367FinicareFC-BP2112023-10-11
06971522820374FinicareFC-BP2202023-10-11
06971522820381FinicareFC-BP2212023-10-11
06971522820336FinicareFC-BP2002023-10-10
06971522820343FinicareFC-BP2012023-10-10
06971522820350FinicareFC-BP2102023-10-10
06971522820497FinicareFC-BP1212023-09-27
06971522820404FinicareFC-BP1302022-08-05
06971522820411FinicareFC-BP1312022-08-05
06971522820244FinicareFC-BP1002022-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.FLL2026-06-03
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
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B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27