AvantSonic

GUDID 06971759810018

AvantSonic Technology Co., Ltd

Bladder volume ultrasound imaging system

• Primary Device ID: 06971759810018
• NIH Device Record Key: 1ed9e8a7-b69c-4a52-bebd-3f42b6c08dc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AvantSonic
• Version Model Number: Z5
• Company DUNS: 544499485
• Company Name: AvantSonic Technology Co., Ltd
• 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
GS1	06971759810018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171528

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

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: 2018-08-10
• Device Publish Date: 2018-07-10

On-Brand Devices [AvantSonic]

• 06971759810025: Z3
• 06971759810018: Z5
• 06971759810032: AS-2
• 06971759810001: AS-1