SOYES Fetal Doppler

GUDID 16970442090390

Vcomin Technlogy Limited

Foetal Doppler system

• Primary Device ID: 16970442090390
• NIH Device Record Key: b1dba713-441a-4e9f-a585-20cae19668e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOYES Fetal Doppler
• Version Model Number: FD-570B
• Company DUNS: 548312355
• Company Name: Vcomin Technlogy Limited
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970442090393 [Primary]
GS1	16970442090390 [Package]; Contains: 06970442090393; Package: Box [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182526

FDA Product Code

• KNG: Monitor, Ultrasonic, Fetal

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: 2021-05-17
• Device Publish Date: 2021-05-08

On-Brand Devices [SOYES Fetal Doppler]

• 16970442090406: FD-570G
• 16970442090390: FD-570B