Omron Platinum Upper Arm Blood Pressure Monitor BP5450

GUDID 10073796265455

Omron automatic digital upper arm blood pressure monitor. Two users with 100 readings of memory storage per user. Bluetooth connectivity.

Omron Healthcare, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID10073796265455
NIH Device Record Key8d8ee005-7762-4fdc-8b96-64aa2decd971
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmron Platinum Upper Arm Blood Pressure Monitor
Version Model NumberBP5450
Catalog NumberBP5450
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 HumidityBetween 10 millibar and 90 millibar

Device Identifiers

Device Issuing AgencyDevice ID
GS100073796265458 [Primary]
GS110073796265455 [Package]
Contains: 00073796265458
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 Date2019-07-01

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
10073796272552 - Omron 5 Series Upper Arm Blood Pressure Monitor2024-04-23 Upper Arm Blood Pressure Monitor w/Bluetooth Connectivity, 30 Memory Storage, Extra Large Display, Irregular Heartbeat Detection
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