Harbor Freight Tools

GUDID 04710953421635

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.

AVITA CORPORATION

Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 04710953421635
• NIH Device Record Key: 640cc804-4fdf-45fa-9d60-50e61d5080c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harbor Freight Tools
• Version Model Number: 58460
• Company DUNS: 658023275
• Company Name: AVITA CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +886285121568
• Email: pin_fan@avita.com.tw
• Phone: +886285121568
• Email: pin_fan@avita.com.tw
• Phone: +886285121568
• Email: pin_fan@avita.com.tw
• Phone: +886285121568
• Email: pin_fan@avita.com.tw
• Phone: +886285121568
• Email: pin_fan@avita.com.tw
• Phone: +886285121568
• Email: pin_fan@avita.com.tw
• Phone: +886285121568
• Email: pin_fan@avita.com.tw
• Phone: +886285121568
• Email: pin_fan@avita.com.tw

Device Identifiers

Device Issuing Agency	Device ID
GS1	04710953421628 [Primary]
GS1	04710953421635 [Package]; Contains: 04710953421628; Package: Paper box [24 Units]; In Commercial Distribution

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-21
• Device Publish Date: 2020-10-13

Devices Manufactured by AVITA CORPORATION

• 04710953421635 - Harbor Freight Tools: 2020-10-21The 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.
• 04710953421635 - Harbor Freight Tools: 2020-10-21 The product automatically measures human begins Systolic, Diastolic blood pressure and pulse rate by oscillometric method. The m
• 04710953421604 - TekCare Non-Contact Infrared Thermometer: 2020-05-25 The NT19 thermometer is designed for the intermittent measurement of the human body's temperature in the domestic environment an
• 04710953421529 - TekCare Touch Free Infrared Thermometer: 2020-04-23 The NT17 THERMO DISTANCE thermometer is designed for the intermittent measurement of the human body's temperature in the domesti
• 04710953421468 - TekCare Green-Type Infrared Thermometer: 2019-12-09 The IR Thermometer is intended to be used as the intermittent measurement of human body temperature for people of all ages.
• 04710953420942 - Blood pressure monitor: 2019-11-08 The device is a wrist type blood pressure monitor intended for automatically measures systolic and diastolic blood pressure and
• 04710953421161 - Blood pressure monitor: 2019-11-08 The device is a arm type blood pressure monitor intended for automatically measures systolic and diastolic blood pressure and pu
• 04710953421345 - TekCare Blood Pressure Monitor: 2019-11-08 BPM19 Series Blood Pressure Monitor applies the Oscillometric method to measure human systolic / diastolic blood pressure and he
• 04710953421307 - TekCare Touch Free Infrared Thermometer: 2019-01-31 The NT11 THERMO DISTANCE thermometer is designed for the intermittent measurement of the human body's temperature in a domestic