Viera Portable Breast Ultrasound 81-02-00011; 50-02-00006

GUDID 07540205000106

Clarius Mobile Health Corp

Hand-held ultrasound imaging system, body-surface

• Primary Device ID: 07540205000106
• NIH Device Record Key: 973af822-8252-4fdb-8dbe-f148f7b75d73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Viera Portable Breast Ultrasound
• Version Model Number: Viera Portable Breast Ultrasound Linear Scanner
• Catalog Number: 81-02-00011; 50-02-00006
• Company DUNS: 202522751
• Company Name: Clarius Mobile Health Corp
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540205000045 [Primary]
GS1	07540205000106 [Direct Marking]
GS1	07540205000205 [Primary]
GS1	07540205000557 [Primary]
GS1	07540205000601 [Primary]
GS1	07540205000670 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172385

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic
• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-21
• Device Publish Date: 2018-03-27

On-Brand Devices [Viera Portable Breast Ultrasound]

• 07540205000649: Viera Battery Charger
• 07540205000106: Viera Portable Breast Ultrasound Linear Scanner