ECO Series Diagnostic Ultrasound Systems

GUDID 06945121407991

CHISON Medical Technologies Co., Ltd.

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• Primary Device ID: 06945121407991
• NIH Device Record Key: 7dfe2eb6-947e-4405-b9e8-8367ed53f240
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECO Series Diagnostic Ultrasound Systems
• Version Model Number: ECO 2
• 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	06945121407328 [Primary]
GS1	06945121407922 [Package]; Contains: 06945121407328; Package: [1 Units]; In Commercial Distribution
GS1	06945121407939 [Package]; Contains: 06945121407328; Package: [1 Units]; In Commercial Distribution
GS1	06945121407946 [Package]; Contains: 06945121407328; Package: [1 Units]; In Commercial Distribution
GS1	06945121407953 [Package]; Contains: 06945121407328; Package: [1 Units]; In Commercial Distribution
GS1	06945121407960 [Package]; Contains: 06945121407328; Package: [1 Units]; In Commercial Distribution
GS1	06945121407977 [Package]; Contains: 06945121407328; Package: [1 Units]; In Commercial Distribution
GS1	06945121407984 [Package]; Contains: 06945121407328; Package: [1 Units]; In Commercial Distribution
GS1	06945121407991 [Package]; Contains: 06945121407328; 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