CBit Series Digital Color Doppler Ultrasound System

GUDID 06945121413398

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 06945121413398
• NIH Device Record Key: 45a94e27-3036-4aa3-9e56-95eafa9819ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CBit Series Digital Color Doppler Ultrasound System
• Version Model Number: XBit 70
• 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	06945121413237 [Primary]
GS1	06945121413398 [Package]; Contains: 06945121413237; Package: [1 Units]; In Commercial Distribution
GS1	06945121414197 [Package]; Contains: 06945121413237; Package: [1 Units]; In Commercial Distribution
GS1	06945121414289 [Package]; Contains: 06945121413237; Package: [1 Units]; In Commercial Distribution
GS1	06945121414296 [Package]; Contains: 06945121413237; Package: [1 Units]; In Commercial Distribution
GS1	06945121414302 [Package]; Contains: 06945121413237; Package: [1 Units]; In Commercial Distribution
GS1	06945121414319 [Package]; Contains: 06945121413237; Package: [1 Units]; In Commercial Distribution
GS1	06945121414326 [Package]; Contains: 06945121413237; Package: [1 Units]; In Commercial Distribution
GS1	06945121414333 [Package]; Contains: 06945121413237; Package: [1 Units]; In Commercial Distribution
GS1	06945121414340 [Package]; Contains: 06945121413237; Package: [1 Units]; In Commercial Distribution
GS1	06945121414357 [Package]; Contains: 06945121413237; Package: [1 Units]; In Commercial Distribution
GS1	06945121414364 [Package]; Contains: 06945121413237; Package: [1 Units]; In Commercial Distribution
GS1	06945121414371 [Package]; Contains: 06945121413237; Package: [1 Units]; In Commercial Distribution
GS1	06945121414388 [Package]; Contains: 06945121413237; Package: [1 Units]; In Commercial Distribution
GS1	06945121414395 [Package]; Contains: 06945121413237; Package: [1 Units]; In Commercial Distribution
GS1	06945121414401 [Package]; Contains: 06945121413237; Package: [1 Units]; In Commercial Distribution
GS1	06945121414463 [Package]; Contains: 06945121413237; Package: [1 Units]; In Commercial Distribution
GS1	06945121414470 [Package]; Contains: 06945121413237; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200780

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: 2021-10-04
• Device Publish Date: 2021-09-26

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