Fetal Doppler FD-530B

GUDID 06970442090416

Vcomin Technlogy Limited

Foetal Doppler system

• Primary Device ID: 06970442090416
• NIH Device Record Key: c0d8ca0c-d4b2-4974-8366-a28b752bbe1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fetal Doppler FD-530B
• Version Model Number: FD-530B
• 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	06970442090416 [Primary]
GS1	16970442090413 [Package]; 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: 2021-09-22
• Device Publish Date: 2021-09-14

Devices Manufactured by Vcomin Technlogy Limited

• 06970442090430 - Fetal Doppler FD-640G: 2021-09-23
• 06970442090416 - Fetal Doppler FD-530B: 2021-09-22
• 06970442090416 - Fetal Doppler FD-530B: 2021-09-22
• 16970442090420 - Fetal Doppler FD-530G: 2021-09-22
• 16970442090338 - VCOMIN Fetal Doppler: 2021-05-17
• 16970442090345 - VCOMIN Fetal Doppler: 2021-05-17
• 16970442090352 - VCOMIN Fetal Doppler: 2021-05-17
• 16970442090369 - VCOMIN Fetal Doppler: 2021-05-17
• 16970442090376 - VCOMIN Fetal Doppler: 2021-05-17