EBit Series Diagnostic Ultrasound System

GUDID 06945121412889

CHISON Medical Technologies Co., Ltd.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 06945121412889
• NIH Device Record Key: 61f3f13b-08ca-483f-9d9c-5d42cf2dc2ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EBit Series Diagnostic Ultrasound System
• Version Model Number: EBit 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	06945121412872 [Primary]
GS1	06945121412889 [Package]; Contains: 06945121412872; Package: [1 Units]; In Commercial Distribution
GS1	06945121413695 [Package]; Contains: 06945121412872; Package: [1 Units]; In Commercial Distribution
GS1	06945121413701 [Package]; Contains: 06945121412872; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162172

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: 2019-09-18
• Device Publish Date: 2019-09-10

On-Brand Devices [EBit Series Diagnostic Ultrasound System]

• 06945121410861: EBit 50
• 06945121409704: EBit 60
• 06945121412889: EBit 30
• 06945121414494: EBit 20