Extra Large D-ring Cuff, Telehealth, Blood Pressure Monitor

GUDID 00073796842314

Omron Healthcare, Inc.

Blood pressure cuff, reusable
Primary Device ID00073796842314
NIH Device Record Key0440a2f8-0742-464e-9aa5-be6cfa017b85
Commercial Distribution StatusIn Commercial Distribution
Brand NameExtra Large D-ring Cuff, Telehealth, Blood Pressure Monitor
Version Model NumberHEM-RXL31
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 Numberfalse
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

Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100073796842314 [Primary]
GS110073796842311 [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 Number4
Public Version Date2019-07-22
Device Publish Date2017-04-26

Devices Manufactured by Omron Healthcare, Inc.

10073796250000 - Iron Upper Arm Blood Pressure Monitor2024-05-23 Upper Arm Blood pressure monitor, automatic inflation, wide range D-ring cuff 9"-17" inches.
10073796251502 - Bronze Upper Arm Blood Pressure Monitor2024-05-23 Upper Arm Blood Pressure Monitor Automatic Inflation with wide range cuff, and 14 memory readings.
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
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.

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