FDA.reportPublic FDA data

hetaida

Primary DI
06970289035946
Brand
hetaida
Company
Hetaida Technology Co., Ltd
Model
H8830US
Device description
Non-contact Infrared Body Thermometer
Published
2026-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
SDVClinical Electronic Thermometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SDVClinical Electronic ThermometerGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970289035943PackageGS1100In Commercial Distribution
06970289035946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697028903594316970289035943
06970289035946069702890359466970289035946

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

Regulatory Flags#

DUNS number
544474402
Device count
1
DM exempt
false
Premarket exempt
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970289035953hetaidaH8830US2026-10-16
06970289035960hetaidaH8601US2026-10-16
06970289035977hetaidaH8601US2026-10-16
06970289030859foreverlittleK8832US2026-07-28
06970289030866foreverlittleH2603US2026-07-28
06970289030118hetaidaHTD8216C2026-05-24
06970289035120hetaidaHTD8823US2026-05-24
06970289035137hetaidaHTD8808C2026-05-23
06970289035144hetaidaHTD8208C2026-05-23
06970289030002Infrared Body ThermometerHTD8216C2019-03-28
06970289030040HetaidaHTD8813C2019-01-10
06970289030057HetaidaHTD8819C2019-01-10
06970289030064Infrared Ear ThermometerHTD8208C2019-03-28
06970289035335HetaidaHTD8808C2021-07-27
06970289035342HetaidaHTD8222US2021-11-06
06970289035397joyhicareH8830US2021-10-29
06970289035496HetaidaHTD8813C2022-03-21
06970289035502HetaidaHTD8813C2022-03-21
06970289035519YOOKOHTD8823US2022-05-31
06970289035670hetaidaHTD8819C2024-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970289035953hetaidaHetaida Technology Co., LtdSDV2026-10-16
06970289035960hetaidaHetaida Technology Co., LtdSDV2026-10-16
06970289035977hetaidaHetaida Technology Co., LtdSDV2026-10-16
00850078377388iHealthiHealth Labs Inc.SDV2026-10-12
00845717012188TrackstarVERIDIAN HEALTHCARE LLCSDV2026-09-04
00311917086569WalgreensWALGREEN CO.SDV2026-08-21
00311917086590WalgreensWALGREEN CO.SDV2026-08-21
00810110303812NuvomedNUVOMED, INC.SDV2026-08-19
00810110305014NuvomedNUVOMED, INC.SDV2026-08-19
06933257923157YUWELL® Infrared ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-08-19
06933257952744YUWELL® Infrared ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-08-19
06933257952751YUWELL® Infrared ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-08-19
06942284618080JOYTECHJOYTECH HEALTHCARE CO.,LTDSDV2026-08-14
10197344219575MEDLINEMEDLINE INDUSTRIES, INC.SDV2026-07-24
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
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