SonoAir Series Digital Color Doppler Ultrasound System

GUDID 06945121414777

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 06945121414777
• NIH Device Record Key: 48b4a518-1da5-4071-ae92-cd4e1227f077
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoAir Series Digital Color Doppler Ultrasound System
• Version Model Number: SonoAir 30
• Company DUNS: 544914187
• Company Name: CHISON Medical Technologies 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945121414777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223570

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: 2023-08-15
• Device Publish Date: 2023-08-07

On-Brand Devices [SonoAir Series Digital Color Doppler Ultrasound System]

• 06945121414777: SonoAir 30
• 06945121414609: SonoAir 70
• 06945121414524: SonoAir 60