CBit Series Digital Color Doppler Ultrasound System

GUDID 06945121413145

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 06945121413145
• NIH Device Record Key: 3bb94b9d-6222-4c42-81b0-172d59e0cb39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CBit Series Digital Color Doppler Ultrasound System
• Version Model Number: CBit 4
• 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	06945121413145 [Primary]
GS1	06945121413497 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	06945121413503 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	06945121413510 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180974

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: 2021-03-17
• Device Publish Date: 2021-03-09

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

• 06945121412933: CBit 6
• 06945121413039: CBit 9
• 06945121413145: CBit 4
• 06945121413220: CBit 5
• 06945121413398: XBit 70
• 06945121413435: CBit 10
• 06945121413480: XBit 90