KOLO

GUDID 06975170000010

Ultrasound Diagnostic System

Kolo Medical (Suzhou) Co., Ltd.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: 06975170000010
• NIH Device Record Key: 40b82267-3be0-4fec-95d9-c5a32accd6a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KOLO
• Version Model Number: Evolution XHD 50
• Company DUNS: 550397899
• Company Name: Kolo Medical (Suzhou) 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	06975170000010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221568

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, 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: 2022-11-04
• Device Publish Date: 2022-10-27

On-Brand Devices [KOLO]

• 06975170000119: Ultrasound transducer
• 06975170000102: Ultrasound transducer
• 06975170000089: Ultrasound transducer
• 06975170000072: Ultrasound transducer
• 06975170000065: Ultrasound Diagnostic System
• 06975170000058: Ultrasound Diagnostic System
• 06975170000041: Ultrasound Diagnostic System
• 06975170000034: Ultrasound Diagnostic System
• 06975170000027: Ultrasound Diagnostic System
• 06975170000010: Ultrasound Diagnostic System