Baby Doppler

GUDID 00628055787013

The Sonoline B Fetal Doppler is an ultrasonic Doppler that allows expectant mothers and health care professionals to retrieve and listen to the fetal heart rate.

DAGAMMA INC.

Foetal Doppler system Foetal Doppler system

• Primary Device ID: 00628055787013
• NIH Device Record Key: bebcbb08-9be0-4510-a69f-9959f223ad5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Baby Doppler
• Version Model Number: Sonoline B Blue 3MHz
• Company DUNS: 080572190
• Company Name: DAGAMMA 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

Customer Support Contacts

• Phone: 8005902767
• Email: support@dagamma.com
• Phone: 8005902767
• Email: support@dagamma.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628055787013 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-30

On-Brand Devices [Baby Doppler]

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• 00628055787051: The Sonoline B Fetal Doppler is a 3MHz ultrasonic Doppler that allows expectant mothers and heal
• 00628055787013: The Sonoline B Fetal Doppler is an ultrasonic Doppler that allows expectant mothers and health c
• 00628055787242: Baby Temp Instant Non-Contact Infrared Thermometer