AQESO

GUDID 06953825903763

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID06953825903763
NIH Device Record Key14e60f43-8f00-482a-a0ef-f4f42bd352d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAQESO
Version Model NumberU83Z
Company DUNS421294358
Company NameShenzhen Urion Technology Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106953825903763 [Primary]
GS106953825903763 [Primary]
GS106953825903763 [Primary]
GS106953825903763 [Primary]
GS106953825903763 [Primary]
GS106953825903763 [Primary]
GS106953825903763 [Primary]
GS106953825903763 [Primary]
GS106953825903763 [Primary]
GS106953825903763 [Primary]
GS106953825903763 [Primary]
GS106953825903763 [Primary]
GS106953825903763 [Primary]
GS106953825903763 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-16
Device Publish Date2020-09-08

On-Brand Devices [AQESO]

06953825903770U62GH
06953825903763U83Z

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