SOYES Fetal Doppler

GUDID 16970442090406

Vcomin Technlogy Limited

Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system

• Primary Device ID: 16970442090406
• NIH Device Record Key: 0d2addcf-e0df-47c9-ab17-0dc1f38032d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOYES Fetal Doppler
• Version Model Number: FD-570G
• 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	06970442090409 [Primary]
GS1	16970442090406 [Package]; Contains: 06970442090409; 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