FDA.report

hetaida

Primary DI
06970289030118
Brand
hetaida
Company
Hetaida Technology Co., Ltd
Model
HTD8216C
Device description
hetaida Infrared Body Thermometer
Published
2026-05-24
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
K180385000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K180385000Infrared Body ThermometerHetaida Technology Co., Ltd.2018-05-11FLL

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16970289030115PackageGS15In Commercial Distribution
26970289030112PackageGS160In Commercial Distribution
06970289030118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1697028903011516970289030115
2697028903011226970289030112
06970289030118069702890301186970289030118

GMDN Terms

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.

Device Sizes

TypeValueUnit
Height0
Length0
Width0

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
06970289035120hetaidaHTD8823US2026-05-24
06970289035137hetaidaHTD8808C2026-05-23
06970289035144hetaidaHTD8208C2026-05-23
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
06970289035120hetaidaHetaida Technology Co., LtdFLL2026-05-24
06970289035137hetaidaHetaida Technology Co., LtdFLL2026-05-23
06970289035144hetaidaHetaida 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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00628693098144ByFloProductsByFlo LLCFLL2026-02-18
16972040113723TizziorShenzhen AOJ Medical Technology Co., LtdFLL2026-02-05
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40328785013984BRAUNKAZ USA, INC.FLL2026-02-04
10328785007975BraunKAZ USA, INC.FLL2026-02-03
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00328785012989BRAUNKAZ USA, INC.FLL2026-02-03
10328785014744BRAUNKAZ USA, INC.FLL2026-02-03
10328785006350VicksKAZ USA, INC.FLL2026-01-28
00328785012798BRAUNKAZ USA, INC.FLL2026-01-28
00328785014655BRAUNKAZ USA, INC.FLL2026-01-28
00328785014662BRAUNKAZ USA, INC.FLL2026-01-27
00328785014716BRAUNKAZ USA, INC.FLL2026-01-27
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06971567043066E+RWenzhou Yosun Medical Technology Co., Ltd.FLL2025-12-29
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10850044118721iHealthIHEALTH LAB INC.FLL2025-12-19