Omron 3 Series Upper Arm Blood Pressure Monitor BP7100CAN

GUDID 00073796100315

3 Series upper arm blood pressure monitor with 14 memory storage and wide range cuff. Easy one-touch operation.

Omron Healthcare, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID00073796100315
NIH Device Record Key4bfeb9a2-f37f-4ca7-a87f-f43443220bcd
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmron 3 Series Upper Arm Blood Pressure Monitor
Version Model NumberBP7100CAN
Catalog NumberBP7100CAN
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

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100073796100315 [Primary]
GS110073796100312 [Package]
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

On-Brand Devices [Omron 3 Series Upper Arm Blood Pressure Monitor]

10073796710023Upper Arm blood pressure monitor with 14-memory storage, irregular heartbeat detection.
000737961003153 Series upper arm blood pressure monitor with 14 memory storage and wide range cuff. Easy one

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