Electronic Blood Pressure Monitor

GUDID 06972040110794

The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.

Shenzhen AOJ Medical Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID06972040110794
NIH Device Record Key0092084b-19ef-4610-9523-82d31beb3fd6
Commercial Distribution StatusIn Commercial Distribution
Brand NameElectronic Blood Pressure Monitor
Version Model NumberAOJ-35D
Company DUNS554409093
Company NameShenzhen AOJ Medical Technology Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106972040110794 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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 Date2021-11-08
Device Publish Date2021-10-29

Devices Manufactured by Shenzhen AOJ Medical Technology Co., Ltd

16972040110678 - DrBash2024-09-06
16972040110715 - DrBash2024-09-06
06972040112514 - Medisana2024-05-31
06972040112538 - Medisana2024-05-31
06972040112545 - Medisana2024-05-31
06972040112552 - Medisana2024-05-31
06972040112569 - Medisana2024-05-31
06972040112576 - Medisana2024-05-31

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