FDA.reportPublic FDA data

FANMI

Primary DI
06953775661737
Brand
FANMI
Company
Alicn Medical Shenzhen, Inc.
Model
AET-R151
Device description
Black
Published
2025-08-28
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
SDVClinical Electronic Thermometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SDVClinical Electronic ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210564000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210564000Infrared ThermometerAlicn Medical Shenzhen, Inc.2022-01-07FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06953775661737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06953775661737069537756617376953775661737

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
548040741
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06953775662529GoodplusAES-U6322026-05-09
06953775662567HauwuteAES-U6122026-05-09
06953775662352HauwuteAES-U6122026-04-21
06953775662376GoodplusAES-U3922026-04-21
06953775662475GoodplusAES-U6322026-04-21
06953775662482GoodplusAES-U6322026-04-21
06953775662505BBLOVEAES-U6222026-04-21
06953775662451@AL21AET-R8522026-04-16
06953775662345BBLOVEAET-F2212026-03-26
06953775662369AILIFEEAET-F2212026-03-26
06953775662383AILIFEEAET-F2412026-03-26
06953775662406BBLOVEAES-U6322026-03-26
06953775662161AILIFEEAES-U5122026-03-07
06953775662277AILIFEEAES-U6222026-03-07
06953775662284BBLOVEAES-U6222026-03-07
06953775662291BBLOVEAES-U1322026-03-07
06953775662239BBLOVEAET-F2312026-01-29
06953775662246AILIFEEAET-F2212026-01-29
06953775662253AILIFEEAES-U5222026-01-29
06953775662079BBLOVEAET-F3712025-11-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015688927HomedicsFKA DISTRIBUTING CO., LLCSDV2026-05-31
06933257929432YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257930711YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257931213YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257931244YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257931251YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257931268YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
10840330706558ProCureTwin Med, LLCSDV2026-05-05
10840330706565ProCureTwin Med, LLCSDV2026-05-05
00860015673107Inito InTemp Basal ThermometerInito Health, Inc.SDV2026-04-08
06953775662345BBLOVEAlicn Medical Shenzhen, Inc.SDV2026-03-26
06953775662369AILIFEEAlicn Medical Shenzhen, Inc.SDV2026-03-26
06953775662383AILIFEEAlicn Medical Shenzhen, Inc.SDV2026-03-26
04719003406516MicrolifeMICROLIFE USA, INC.SDV2026-01-31
04719883871350Fore HealthFORTECHGRP CO., LTD.SDV2026-01-28
04719883871374Fore HealthFORTECHGRP CO., LTD.SDV2026-01-28
04719883871381Fore HealthFORTECHGRP CO., LTD.SDV2026-01-28
04719883871435Fore HealthFORTECHGRP CO., LTD.SDV2026-01-28
04719883870070ForeHealthFORTECHGRP CO., LTD.SDV2026-01-26
00194346614042EquateWAL-MART STORES, INC.SDV2026-01-21
06947656117932BERRCOMGuangzhou Berrcom Medical Device Co., LtdSDV2026-01-21
06947656118014BerrcomGuangzhou Berrcom Medical Device Co., LtdSDV2026-01-21
06947656118021DedeksGuangzhou Berrcom Medical Device Co., LtdSDV2026-01-21
06947656118038DedeksGuangzhou Berrcom Medical Device Co., LtdSDV2026-01-21
06947656118045DedeksGuangzhou Berrcom Medical Device Co., LtdSDV2026-01-21
06947656118052BERRCOMGuangzhou Berrcom Medical Device Co., LtdSDV2026-01-21
00850044118694iHealthiHealth Labs Inc.SDV2025-12-19
00850044118700iHealthiHealth Labs Inc.SDV2025-12-19
00850044118724iHealthiHealth Labs Inc.SDV2025-12-19
00860013187774PLAYHOUSE MDPLAYHOUSE METHOD INC.SDV2025-12-17