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

Devices Manufactured by OMNIA MEDICAL, LLC

• 00843511111823 - Omnia Medical TiBrid™-SA: 2024-06-20 TiBrid™-SA PLATE, 30mm, L1-L5
• 00843511111830 - Omnia Medical TiBrid™-SA: 2024-06-20 TiBrid™-SA PLATE, 32mm, L1-L5
• 00843511111847 - Omnia Medical TiBrid™-SA: 2024-06-20 TiBrid™-SA PLATE, 34mm, L1-L5
• 00843511111854 - Omnia Medical TiBrid™-SA: 2024-06-20 TiBrid™-SA PLATE, 36mm, L1-L5
• 00843511111861 - Omnia Medical TiBrid™-SA: 2024-06-20 TiBrid™-SA PLATE, 38mm, L1-L5
• 00843511112585 - TiBrid-SA: 2024-06-20 TiBrid-SA Half Moon Inserter (Custom)
• 00843511112592 - Omnia Medical TiBrid SA: 2024-06-20 U-JOINT AWL SHORTENED TIP (special)
• 00843511112851 - Omnia Medical TiBrid™-SA: 2024-06-20 TiBrid™-SA PLATE, 30mm, L5-S1