My Baby's Heartbeat Bear Fetal Doppler

GUDID 16970442090314

Vcomin Technlogy Limited

Foetal Doppler system

• Primary Device ID: 16970442090314
• NIH Device Record Key: e04f7a5d-d4cd-4b21-ab83-78ab73ab51cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: My Baby's Heartbeat Bear Fetal Doppler
• Version Model Number: FD-590B
• 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	06970442090317 [Primary]
GS1	16970442090314 [Package]; Contains: 06970442090317; 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: 2020-12-03
• Device Publish Date: 2020-11-25