FDA.reportPublic FDA data

Hetaida

Primary DI
16970289035356
Brand
Hetaida
Company
Hetaida Technology Co., Ltd
Model
HTD8219US
Device description
Infrared Body Thermometer
Published
2021-09-14
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200781000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200781000Infrared Body ThermometerHeitaida Technology Co., Ltd.2020-12-09FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970289035356PackageGS136In Commercial Distribution
06970289035359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697028903535616970289035356
06970289035359069702890353596970289035359

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+86076982658050tomchen@hetaida.com.cn

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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
06970289035687HetaidaHTD6603US2024-03-14
06970289035694HetaidaH2605US2024-03-14
06970289035724HetaidaHTD2601US2024-08-15
06970289035731HetaidaHTD2602US2024-08-15
00199874040318VIEKHTD8816C2026-05-12

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Primary DI, Brand, Company table
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00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
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06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22