J5 Diagnostic Ultrasound System

GUDID 06944904091860

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 06944904091860
• NIH Device Record Key: 7f83d44c-d345-40ee-97b6-fc2b339f61bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: J5 Diagnostic Ultrasound System
• Version Model Number: TCN16-GG005-F-AA
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944904091860 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161525

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-09

On-Brand Devices [J5 Diagnostic Ultrasound System]

• 06944904092638: TCN17-GG001-F-AA
• 06944904091860: TCN16-GG005-F-AA