Omron Easy Wrap Comfit Cuff HEM-FL31-B

GUDID 10073796361720

Optional blood pressure monitor cuff, preformed 9" to 17"

Omron Healthcare, Inc.

Blood pressure cuff, reusable
Primary Device ID10073796361720
NIH Device Record Key3909064e-7b5d-4486-a309-53501928583e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmron Easy Wrap Comfit Cuff
Version Model NumberHEM-FL31-B
Catalog NumberHEM-FL31-B
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100073796361723 [Primary]
GS110073796361720 [Package]
Contains: 00073796361723
Package: case [20 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 Date2019-07-22
Device Publish Date2019-05-01

Devices Manufactured by Omron Healthcare, Inc.

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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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