Blood Pressure Monitor

GUDID 06972797030116

This is an arm type blood pressure monitor. The monitor features blood pressure measurement, pulse rate measurement and the result storage.

Shenzhen Yuangu Technology Co., Ltd.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID06972797030116
NIH Device Record Key3529fde2-bb76-4fec-8e24-8b54019373be
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlood Pressure Monitor
Version Model NumberTMB-1583-S
Company DUNS417870361
Company NameShenzhen Yuangu 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 Batchfalse
Serial Numbertrue
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
GS106972797030116 [Primary]
GS136972797030117 [Package]
Package: Carton [18 Units]
In Commercial Distribution

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 Date2019-11-27
Device Publish Date2019-11-19

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