Fusion Imaging Kit(CE/FDA/With Trolley)

GUDID 06944904091976

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 06944904091976
• NIH Device Record Key: ad0c500f-979e-42c3-be5f-cfc3faf09a52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion Imaging Kit(CE/FDA/With Trolley)
• Version Model Number: 115-041415-00
• 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: false
• Manufacturing Date: false
• 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	06944904091976 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171233

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-23
• Device Publish Date: 2019-12-14

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