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 ID: 10073796361720
• NIH Device Record Key: 3909064e-7b5d-4486-a309-53501928583e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron Easy Wrap Comfit Cuff
• Version Model Number: HEM-FL31-B
• Catalog Number: HEM-FL31-B
• Company DUNS: 054318779
• Company Name: Omron Healthcare, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-634-4350
• Email: ohiquality@omron.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796361723 [Primary]
GS1	10073796361720 [Package]; Contains: 00073796361723; Package: case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133383

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-22
• Device Publish Date: 2019-05-01

Devices Manufactured by Omron Healthcare, Inc.

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• 10073796252554 - Silver Upper Arm Blood Pressure Monitor: 2024-05-23 Upper Arm Blood Pressure Monitor w/Bluetooth Connectivity, 30 Reading Memory, Easy Wrap ComFit Cuff
• 10073796271500 - 3 Series Upper Arm Blood Pressure Monitor: 2024-04-23 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 Monitor: 2024-04-23 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 Monitor: 2022-08-09
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• 00073796930004 - Blood Pressure Monitor: 2022-06-09 Telehealth Blood Pressure Monitor with range cup 9-17 inch.