Delica

GUDID 06970481940093

Shenzhen Delica Medical Equipment Co., Ltd.

Noninvasive vascular ultrasound system probe

• Primary Device ID: 06970481940093
• NIH Device Record Key: 04f135cf-4ed2-4f9a-a1ed-d24958308d7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delica
• Version Model Number: EMS-9D PRO
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	06970481940093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190228

FDA Product Code

• DXQ: Blood Pressure Cuff

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-22
• Device Publish Date: 2019-06-20

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