Extra large D-ring Cuff for Telehealth Blood Pressure Monitor HEM-RXL31-B

GUDID 10073796423121

Omron Healthcare, Inc.

Blood pressure cuff, reusable

• Primary Device ID: 10073796423121
• NIH Device Record Key: 88d2412f-4e9b-4c6f-9f44-6bb438685e87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Extra large D-ring Cuff for Telehealth Blood Pressure Monitor
• Version Model Number: HEM-RXL31-B
• Catalog Number: HEM-RXL31-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
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796423124 [Primary]
GS1	10073796423121 [Package]; Contains: 00073796423124; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163235

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-09
• Device Publish Date: 2022-08-01

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