Omron 7 Series Connected Upper Arm Blood Pressure Monitor BP7350

GUDID 10073796267350

Upper arm blood pressure monitor with Bluetooth connectivity, 2 user modes and 60 readings per user.

Omron Healthcare, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID10073796267350
NIH Device Record Key7dc60db7-a6d5-43f3-b9cc-cd166a88d12f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmron 7 Series Connected Upper Arm Blood Pressure Monitor
Version Model NumberBP7350
Catalog NumberBP7350
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

Phone1-800-634-4350
Emailohiquality@omron.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100073796267353 [Primary]
GS110073796267350 [Package]
Contains: 00073796267353
Package: [10 Units]
In Commercial Distribution
GS150073796267358 [Package]
Contains: 00073796267353
Package: Inner Carton [2 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 Number3
Public Version Date2019-11-08
Device Publish Date2019-05-15

Devices Manufactured by Omron Healthcare, Inc.

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10073796252554 - Silver Upper Arm Blood Pressure Monitor2024-05-23 Upper Arm Blood Pressure Monitor w/Bluetooth Connectivity, 30 Reading Memory, Easy Wrap ComFit Cuff
10073796271500 - 3 Series Upper Arm Blood Pressure Monitor2024-04-23 Automatic inflation upper arm blood pressure monitor with wide range cuff. (9-17 inch), Bluetooth connectivity, 14 memory storag
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