FDA.reportPublic FDA data

North American Health Wellness

Primary DI
06926347921614
Brand
North American Health Wellness
Company
Shenzhen Brav Electronic Technologies Co., Ltd.
Model
JB8408
Device description
EFT-161 measures the body temperature through receiving the infrared energy radiation from the surface of objects. It is with forehead temperature mode,and ear temperature mode. The measurement result directly shows on the LCD screen, It is easy, hygiene and accurate. The device is widely used for home healthcare, medical institutes and many other occasions.
Published
2019-08-22
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06926347921614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06926347921614069263479216146926347921614

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.

Regulatory Flags#

DUNS number
421279648
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06926347900459joybabeEFT-1662026-06-01
06926347901647BRAVEFT-1642019-05-07
06926347901661BRAVEFT-1662019-08-22
06926347911653BRAVEFT-1652019-08-22
06926347917419BRAVIT-121S2020-06-19
06926347911615SMARTROEFT-1612019-05-08
06926347901616BRAVEFT-1612018-06-25
06926347901623BRAVEFT-1622018-06-25
06926347901630BRAVEFT-1632018-06-26
06926347900367RUNSTARBP-2062026-04-30
06926347932160RUNSTARBP-2012026-04-16
06926347966691RUNSTARBP-2052026-04-16
06926347961061eclat essenceBV-609(WF01)2025-07-10
06926347961078eclat essenceBV-609(WF02)2025-07-10
06926347968916eclat essenceBV-612(WF03)2025-07-10
06926347968923eclat essenceBV-612(WF04)2025-07-10
06926347965021TrustownBP-2022025-04-14
06926347918515BRAVBV-6122025-03-31
06926347962617BRAVBV-6102025-03-31
06926347905164RUNSTARBP-2062024-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
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08698870325310FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
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