Tee probe

GUDID 06945121410311

CHISON Medical Technologies Co., Ltd.

Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable

• Primary Device ID: 06945121410311
• NIH Device Record Key: 1418eb74-1c9e-459d-937b-a4aa8974f593
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tee probe
• Version Model Number: MT5-E
• 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	06945121409995 [Primary]
GS1	06945121410311 [Package]; Contains: 06945121409995; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162172

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Tee probe]

• 06945121410311: MT5-E
• 06945121410304: T5-E
• 06945121403306: T5P64L
• 06945121400299: MT5P48L
• 06945121400282: T5P64L