Neeva Baby

GUDID 00860005571901

The Neeva Baby Fetal Doppler is an ultrasonic Doppler that allows expectant mothers and health care professionals to retrieve and listen to the fetal heart

Sebe Inc

Foetal Doppler system

• Primary Device ID: 00860005571901
• NIH Device Record Key: 937b7c11-ec1a-4747-a34f-f8b68bd8f7c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neeva Baby
• Version Model Number: NB Fetal Doppler 2MHz
• Company DUNS: 204186571
• Company Name: Sebe Inc
• 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: false
• Expiration Date: false
• 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	00860005571901 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082480

FDA Product Code

• KNG: Monitor, Ultrasonic, Fetal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-26
• Device Publish Date: 2020-10-18

On-Brand Devices [Neeva Baby]

• 00860005571925: The Neeva Baby Fetal Doppler Mini is an ultrasonic Doppler that allows expectant mothers and hea
• 00860005571901: The Neeva Baby Fetal Doppler is an ultrasonic Doppler that allows expectant mothers and health c
• 00860005571932: The Neeva Baby Fetal Doppler is an ultrasonic Doppler that allows expectant mothers and health c
• 00860005571987: Neeva Baby Heart Monitor