Delica

GUDID 06970481940048

Transcranial Doppler Ultrasound System with Robotic Probe Headband

Shenzhen Delica Medical Equipment Co., Ltd.

Noninvasive vascular ultrasound system, line-powered

• Primary Device ID: 06970481940048
• NIH Device Record Key: 33d0c778-7091-47e8-9bb6-7f584c8c96b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delica
• Version Model Number: EMS-9PB
• Company DUNS: 544412009
• Company Name: Shenzhen Delica Medical Equipment Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• 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	06970481940048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122710

FDA Product Code

• OQQ: Diagnostic Ultrasonic Transducer, Robotic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-06-21
• Device Publish Date: 2016-09-19

On-Brand Devices [Delica]

• 06970481940024: Transcranial Doppler Ultrasound System
• 06970481940017: Transcranial Doppler Ultrasound System
• 06970481940086: Transcranial Doppler Ultrasound System
• 06970481940079: Transcranial Doppler Ultrasound System
• 06970481940048: Transcranial Doppler Ultrasound System with Robotic Probe Headband
• 06970481940031: Transcranial Doppler Ultrasound System with Robotic Probe Headband
• 06970481940109: EMS-9D EXP
• 06970481940093: EMS-9D PRO
• 06970481940178: EMS-9M1
• 06970481940161: EMS-9M2