Home GUDID 04710953421635
Harbor Freight Tools
Primary DI 04710953421635
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
Rx false
OTC true
Sterile false
Single use false
Product Codes# Code, Name table Code Name DXN System, Measurement, Blood-Pressure, Non-Invasive
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04710953421635 Package GS1 24 In Commercial Distribution 04710953421628 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04710953421635 04710953421635 4710953421635 04710953421628 04710953421628 4710953421628
GMDN Terms# Term, Definition table Term Definition Automatic-inflation electronic sphygmomanometer, non-portable An 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.
Regulatory Flags# DUNS number 658023275 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06953825911515 N/A Shenzhen Urion Technology Co., Ltd DXN 2026-07-16 00850044118670 iHealth iHealth Labs Inc. DXN 2026-07-14 00850044118687 iHealth iHealth Labs Inc. DXN 2026-07-14 00850078377234 iHealth iHealth Labs Inc. DXN 2026-07-14 06953825911416 N/A Shenzhen Urion Technology Co., Ltd DXN 2026-07-13 00845717011556 N/A Shenzhen AOJ Medical Technology Co., Ltd DXN 2026-07-11 00845717011563 N/A Shenzhen AOJ Medical Technology Co., Ltd DXN 2026-07-11 06972040112842 N/A Shenzhen AOJ Medical Technology Co., Ltd DXN 2026-07-11 06972040113481 N/A Shenzhen AOJ Medical Technology Co., Ltd DXN 2026-07-11 06972040114358 N/A Shenzhen AOJ Medical Technology Co., Ltd DXN 2026-07-11 06972040114365 N/A Shenzhen AOJ Medical Technology Co., Ltd DXN 2026-07-11 06972040117397 N/A Shenzhen AOJ Medical Technology Co., Ltd DXN 2026-07-11 MHC18602130 N/A Shenzhen AOJ Medical Technology Co., Ltd DXN 2026-07-11 06953825911294 N/A Shenzhen Urion Technology Co., Ltd DXN 2026-07-09 06953825911300 N/A Shenzhen Urion Technology Co., Ltd DXN 2026-07-09 06953825911317 Alphamed Shenzhen Urion Technology Co., Ltd DXN 2026-07-09 06953825911355 N/A Shenzhen Urion Technology Co., Ltd DXN 2026-07-09 06953825911393 N/A Shenzhen Urion Technology Co., Ltd DXN 2026-07-09 04250413403578 Cuff ABPMpro without ECG SOMNOmedics AG DXN 2026-07-07 04250413403585 Cuff ABPMpro without ECG SOMNOmedics AG DXN 2026-07-07 04250413406456 Cuff ABPMpro for right arm SOMNOmedics AG DXN 2026-07-07 04250413406463 Cuff ABPMpro for right arm SOMNOmedics AG DXN 2026-07-07 06927709404608 JALIP Shenzhen Jamr Technology Co., Ltd. DXN 2026-07-06 06927709404622 WellWink Shenzhen Jamr Technology Co., Ltd. DXN 2026-07-06 06973912940419 IMDK Shenzhen IMDK Medical Technology Co., Ltd DXN 2026-06-23 06973912940426 IMDK Shenzhen IMDK Medical Technology Co., Ltd DXN 2026-06-23 06926347900497 POSTURE Shenzhen Brav Electronic Technologies Co., Ltd. DXN 2026-06-09 06953825911041 ELERA Shenzhen Urion Technology Co., Ltd DXN 2026-06-03 06953825911188 sakerplus Shenzhen Urion Technology Co., Ltd DXN 2026-06-03 06953825911218 Alphamed Shenzhen Urion Technology Co., Ltd DXN 2026-06-03