Omron Gold, Wrist Blood Pressure Monitor BP4350

GUDID 10073796264359

Wrist Blood Pressure - 100 readings per user (2 users), Bluetooth Connectivity, Ultra Silent Inflation.

Omron Healthcare, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID10073796264359
NIH Device Record Key67733893-039f-4738-b3d6-b539aa894c3d
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmron Gold, Wrist Blood Pressure Monitor
Version Model NumberBP4350
Catalog NumberBP4350
Company DUNS054318779
Company NameOmron Healthcare, Inc.
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 Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-634-4350
Emailohiquality@omron.com

Operating and Storage Conditions

Handling Environment HumidityBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100073796264352 [Primary]
GS110073796264359 [Package]
Contains: 00073796264352
Package: Case [10 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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-07-08

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