Phased array probe

GUDID 06945121400244

CHISON Medical Technologies Co., Ltd.

Foetal Doppler system probe

• Primary Device ID: 06945121400244
• NIH Device Record Key: bfb5e1b1-681c-484a-91c1-45e60087ebdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phased array probe
• Version Model Number: D3P64L
• 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	06945121400244 [Primary]
GS1	06945121410809 [Package]; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153085

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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 [Phased array probe]

• 06945121411707: P5-V
• 06945121411691: P3T-V
• 06945121411684: P2-V
• 06945121411615: T5-V
• 06945121408363: P3
• 06945121407502: P3-A
• 06945121400268: D2P64L
• 06945121400251: D6P64L
• 06945121400244: D3P64L
• 06945121413657: P3T-T
• 06945121414005: P2M-T
• 06945121414555: 3S