L12-4s Ultrasonic Transducer(SMS)

GUDID 06944904097008

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 06944904097008
• NIH Device Record Key: f579d9d4-1986-4d01-9272-645b1c7c9885
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L12-4s Ultrasonic Transducer(SMS)
• Version Model Number: 120-005508-00
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944904097008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171034
• Premarket Notification: K172970

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

[06944904097008]

Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-15
• Device Publish Date: 2018-07-15

Devices Manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

• 06944904064659 - DC-30: 2025-02-18
• 06944904099781 - DC-25: 2025-02-18
• 06944904099798 - DC-26: 2025-02-18
• 06944904099804 - DC-28: 2025-02-18
• 06944904099811 - DC-32: 2025-02-18
• 06903053012355 - Consona AE Diagnostic Ultrasound System: 2025-02-17
• 06903053012379 - Consona AR Diagnostic Ultrasound System: 2025-02-17
• 06903053012386 - Consona AT Diagnostic Ultrasound System: 2025-02-17