ECO Series Diagnostic Ultrasound Systems

GUDID 06945121407915

CHISON Medical Technologies Co., Ltd.

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• Primary Device ID: 06945121407915
• NIH Device Record Key: d2132ace-f318-4b47-b4a6-07e143c2a19d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECO Series Diagnostic Ultrasound Systems
• Version Model Number: ECO 1
• 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	06945121407311 [Primary]
GS1	06945121407847 [Package]; Contains: 06945121407311; Package: [1 Units]; In Commercial Distribution
GS1	06945121407854 [Package]; Contains: 06945121407311; Package: [1 Units]; In Commercial Distribution
GS1	06945121407861 [Package]; Contains: 06945121407311; Package: [1 Units]; In Commercial Distribution
GS1	06945121407878 [Package]; Contains: 06945121407311; Package: [1 Units]; In Commercial Distribution
GS1	06945121407885 [Package]; Contains: 06945121407311; Package: [1 Units]; In Commercial Distribution
GS1	06945121407892 [Package]; Contains: 06945121407311; Package: [1 Units]; In Commercial Distribution
GS1	06945121407908 [Package]; Contains: 06945121407311; Package: [1 Units]; In Commercial Distribution
GS1	06945121407915 [Package]; Contains: 06945121407311; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131305

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [ECO Series Diagnostic Ultrasound Systems]

• 06945121408158: ECO 5
• 06945121408073: ECO 3
• 06945121407991: ECO 2
• 06945121407915: ECO 1