Automatic Blood Pressure Monitor with memory and Printer

GUDID 00073796705367

Omron Healthcare, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID00073796705367
NIH Device Record Key9e98dfd4-cd43-4c09-8a56-097b0133c47d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutomatic Blood Pressure Monitor with memory and Printer
Version Model NumberHEM-705CPN
Company DUNS054318779
Company NameOmron Healthcare, Inc.
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100073796705367 [Primary]
GS110073796705364 [Package]
Package: Inner Carton [3 Units]
In Commercial Distribution
GS120073796705361 [Package]
Contains: 10073796705364
Package: Case [4 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 Number5
Public Version Date2019-11-08
Device Publish Date2017-01-25

Devices Manufactured by Omron Healthcare, Inc.

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10073796423121 - Extra large D-ring Cuff for Telehealth Blood Pressure Monitor2022-08-09
10073796893108 - Blood Pressure Monitor 2022-07-11 Telehealth Blood Pressure Monitor with extra large cuff compatibility.
00073796930004 - Blood Pressure Monitor 2022-06-09 Telehealth Blood Pressure Monitor with range cup 9-17 inch.
10073796711020 - Omron Upper Arm Blood Pressure Monitor2021-09-23 Upper arm blood pressure monitor - One-touch operation - 30 memory storage - irregular heartbeat detection
00073796507206 - No-Touch Forehead Thermometer2021-09-09 No-touch forehead thermometer with fast 1 second measurement and high temperature notification. 25 memory reading.
00073796745530 - Omron Blood Pressure Monitor2021-09-09 Blood Pressure Monitor w/Bluetooth, Comparison Display, pre-formed Comfit Cuff, irregular heartbeat detector and 200 memory stor

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