FDA.reportPublic FDA data

Harbor Freight Tools

Primary DI
04710953421628
Brand
Harbor Freight Tools
Company
AVITA CORPORATION
Model
58460
Device description
The product automatically measures human begins Systolic, Diastolic blood pressure and pulse rate by oscillometric method. The measurement results are displayed on the LCD. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults with wrist circumference ranging from 125 mm to 210 mm (Approx.4.9 ~ 8.3 inches) and for home use. When the device detects the appearance of irregular heartbeats such as atrial or ventricular premature beats during measurement, an indicated symbol will appear with measuring readings. This device is designed only for adults.
Published
2020-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04710953421635PackageGS124In Commercial Distribution
04710953421628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04710953421635047109534216354710953421635
04710953421628047109534216284710953421628

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, non-portableAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is not designed to be portable and is typically used bedside.

Contacts#

Phone, Email table
PhoneEmail
+886285121568pin_fan@avita.com.tw

Regulatory Flags#

DUNS number
658023275
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04710953421635Harbor Freight Tools584602020-10-13
04710953421598TekCare Non-Contact Infrared ThermometerNT192020-05-15
04710953421604TekCare Non-Contact Infrared ThermometerNT192020-05-15
04710953421512TekCare Touch Free Infrared ThermometerNT172020-04-15
04710953421529TekCare Touch Free Infrared ThermometerNT172020-04-15
04710953421468TekCare Green-Type Infrared ThermometerNT1G2019-11-29
04710953421338TekCare Blood Pressure MonitorBPM192018-12-31
04710953420942Blood pressure monitor622202017-04-24
04710953421161Blood pressure monitorBPA-O3002018-08-12
04710953421345TekCare Blood Pressure MonitorBPM192018-12-31
04710953421291TekCare Touch Free Infrared ThermometerNT112018-12-31
04710953421314TekCare Infrared ThermometerTS462018-12-31
04710953421307TekCare Touch Free Infrared ThermometerNT112018-12-31
04710953421321TekCare Infrared ThermometerTS462018-12-31

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Primary DI, Brand, Company table
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