P8-3mTEE Ped Echocardiography Transducer

GUDID 06944904098746

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 06944904098746
• NIH Device Record Key: 969526d1-4143-439a-83f2-5b57e286b397
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P8-3mTEE Ped Echocardiography Transducer
• Version Model Number: P8-3mTEE
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944904098746 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171891

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[06944904098746]

Liquid Chemical

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-27
• Device Publish Date: 2018-07-26

On-Brand Devices [P8-3mTEE Ped Echocardiography Transducer]

• 06944904098746: P8-3mTEE
• 06936415903787: Z131-00