Accuro

GUDID B015000010

RIVANNA MEDICAL, LLC

Hand-held ultrasound imaging system, body-surface

• Primary Device ID: B015000010
• NIH Device Record Key: 442c1315-02c1-47e0-bf3a-12620f4c2eb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accuro
• Version Model Number: 00001
• Company DUNS: 962721333
• Company Name: RIVANNA 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B015000010 [Primary]
HIBCC	B015000011 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132736

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-12-21
• Device Publish Date: 2016-07-22