Cura Bluetooth Blood Pressure Monitor LS810-B

GUDID 00843511100711

OMNIA MEDICAL, LLC

Patient monitoring system module, blood pressure, noninvasive

• Primary Device ID: 00843511100711
• NIH Device Record Key: f34ca9ed-1d2e-41e9-ba5d-e777da5ceef6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cura Bluetooth Blood Pressure Monitor
• Version Model Number: LS810-B
• Catalog Number: LS810-B
• Company DUNS: 079467378
• Company Name: OMNIA MEDICAL, LLC
• 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: false

Customer Support Contacts

• Phone: 3044134851
• Email: customerservice@omniamedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843511100711 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123669

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: 2020-03-06
• Device Publish Date: 2020-02-27

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