P8-3TEE Echocardiography Transducer

GUDID 06944904097152

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 06944904097152
• NIH Device Record Key: 224e4a58-9f57-4632-85ee-482a62e9c9e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P8-3TEE Echocardiography Transducer
• Version Model Number: Z115-JP
• Company DUNS: 654671304
• Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944904097152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151175

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: 2017-12-07

On-Brand Devices [P8-3TEE Echocardiography Transducer]

• 06944904097152: Z115-JP
• 06944904097145: Z115-08
• 06944904093000: Z115-00
• 06936415906245: P8-3TEE