Home GUDID B146ZT2776A00210 higi SZZT
Primary DI B146ZT2776A00210
Brand higi SZZT
Company HIGI SH LLC
Model ZT2776A0021
Catalog number n/a
Device description The higi Station is intended for use by the general public to measure blood pressure, pulse, body weight, percent body fat, percent lean body mass, total body water and calculate body mass index. It is not a diagnostic device and only furnishes data so that users can consult their personal physician or other healthcare professional. The user can choose to store or send the data to a personal physician or healthcare professional. Users must be 13 years of age to use the higi Station.
Published 2018-09-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 B146ZT2776A00210 Primary HIBCC 0
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 079773850 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B416KMY8202F0 Higi Green (KMY) KMY-120630950-117 n/a 2018-09-20 B416SH650 Higi White 1301252105 n/a 2018-09-20
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00093764604737 A&D Medical A&D COMPANY, LIMITED DXN 2026-09-25 00093764604744 A&D Medical A&D COMPANY, LIMITED DXN 2026-09-25 06953825911874 AlphaMed Shenzhen Urion Technology Co., Ltd DXN 2026-09-22 06953825911850 sakerplus Shenzhen Urion Technology Co., Ltd DXN 2026-09-18 06920485308580 P PANACARE Shenzhen BSX Technology Electronics Co., Ltd. DXN 2026-08-26 06944413835153 Telemetry Monitor Edan Instruments, Inc. DXN 2026-08-26 06944413835214 Telemetry Monitor Edan Instruments, Inc. DXN 2026-08-26 00634782102265 Advantage™ AMERICAN DIAGNOSTIC CORP DXN 2026-08-25 00810226442306 Vive VIVE HEALTH LLC DXN 2026-08-25 00856324008778 PARAMED SILEX GLOBAL LLC DXN 2026-08-22 06971522821753 Lineshare Shenzhen Finicare Co., Ltd DXN 2026-08-22 06971522821760 Lineshare Shenzhen Finicare Co., Ltd DXN 2026-08-22 06953825911805 FOCUSED ADULT ADHD CLINIC Shenzhen Urion Technology Co., Ltd DXN 2026-08-19 09120073932778 CNAP® Armsling CNSystems Medizintechnik GmbH DXN 2026-08-18 09120073932785 CNAP® double finger cuff "small" CNSystems Medizintechnik GmbH DXN 2026-08-18 09120073932792 CNAP® double finger cuff "medium" CNSystems Medizintechnik GmbH DXN 2026-08-18 09120073932808 CNAP® double finger cuff "large" CNSystems Medizintechnik GmbH DXN 2026-08-18 09120073932815 CNAP® double finger cuff "small" CNSystems Medizintechnik GmbH DXN 2026-08-18 09120073932822 CNAP® double finger cuff "medium" CNSystems Medizintechnik GmbH DXN 2026-08-18 09120073932839 CNAP® double finger cuff "large" CNSystems Medizintechnik GmbH DXN 2026-08-18 09120073932846 CNAP® double finger cuff "small" CNSystems Medizintechnik GmbH DXN 2026-08-18 09120073932853 CNAP® double finger cuff "medium" CNSystems Medizintechnik GmbH DXN 2026-08-18 09120073932860 CNAP® double finger cuff "large" CNSystems Medizintechnik GmbH DXN 2026-08-18 09120073932877 CNAP® double finger cuff "small" CNSystems Medizintechnik GmbH DXN 2026-08-18 09120073932884 CNAP® double finger cuff "medium" CNSystems Medizintechnik GmbH DXN 2026-08-18 09120073932891 CNAP® double finger cuff "large" CNSystems Medizintechnik GmbH DXN 2026-08-18 09120073933034 CNAP® Armsling "small" CNSystems Medizintechnik GmbH DXN 2026-08-18 09120073933041 TFC Armsling "small" CNSystems Medizintechnik GmbH DXN 2026-08-18 06953825911799 SAKER Shenzhen Urion Technology Co., Ltd DXN 2026-08-17 06920485308542 BSX Shenzhen BSX Technology Electronics Co., Ltd. DXN 2026-08-14