FDA.report

hetaida

Primary DI
06970289035144
Brand
hetaida
Company
Hetaida Technology Co., Ltd
Model
HTD8208C
Device description
Infrared Ear Thermometer
Published
2026-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions

SubmissionSupplement
K180387000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K180387000Infrared Ear ThermometerHetaida Technology Co., Ltd.2019-01-10FLL

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16970289035141PackageGS140In Commercial Distribution
06970289035144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1697028903514116970289035141
06970289035144069702890351446970289035144

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags

DUNS number
544474402
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06970289030118hetaidaHTD8216C2026-05-24
06970289035120hetaidaHTD8823US2026-05-24
06970289035137hetaidaHTD8808C2026-05-23
06970289035908HomedicsTIE-240B-BABY2025-06-20
06970289035915HomedicsTIE-240B2025-06-20
16970289035837HetaidaHTD8813C2025-05-12
16970289035844HetaidaK5102US2025-05-12
16970289035851HetaidaD6607US2025-05-12
16970289035868HetaidaHTD6101US2025-05-12
16970289035820HetaidaD6606US2025-05-09
16970289035752CARE VISIONHTD6603US2024-11-30
16970289035769CARE VISIOND6606US2024-11-30
16970289035325HetaidaHTD8813C2021-07-27
16970289035332HetaidaHTD8808C2021-07-27
16970289035561HetaidaHTD8813C2022-12-23
16970289035721HetaidaHTD2601US2024-08-15
16970289035738HetaidaHTD2602US2024-08-15
16970289035660OptimalH8228US2024-05-29
16970289035714NAHTD8808C2024-05-23
16970289035653HetaidaD6606US2024-05-02

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Primary DIBrandCompanyProduct codePublished
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06970289035120hetaidaHetaida Technology Co., LtdFLL2026-05-24
06970289035137hetaidaHetaida Technology Co., LtdFLL2026-05-23
06953205995043Infrared ThermometerShenzhen Jiacom Technology Co., LtdFLL2026-03-20
00850022483370Dr. Noze Best ThermometerDr. Noze Best, LLCFLL2026-03-17
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00328785014662BRAUNKAZ USA, INC.FLL2026-01-27
00328785014716BRAUNKAZ USA, INC.FLL2026-01-27
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