AVANTSONIC

GUDID 06971759810001

AvantSonic Technology Co., Ltd

Bladder volume ultrasound imaging system

• Primary Device ID: 06971759810001
• NIH Device Record Key: 7a91f9e8-52c5-460a-b37a-0fcb10499798
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVANTSONIC
• Version Model Number: AS-1
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971759810001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230986

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: 2024-03-22
• Device Publish Date: 2024-03-14

On-Brand Devices [AVANTSONIC]

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