Baby Doppler

GUDID 00628055787051

The Sonoline B Fetal Doppler is a 3MHz ultrasonic Doppler that allows expectant mothers and health care professionals to retrieve and listen to the fetal heart rate.

DAGAMMA INC.

Foetal Doppler system

• Primary Device ID: 00628055787051
• NIH Device Record Key: e8e6d628-552f-45ca-aef3-ed3ca428e206
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Baby Doppler
• Version Model Number: Sonoline B Pink 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: 1-800-590-2767
• Email: support@dagamma.com
• Phone: 1-800-590-2767
• Email: support@dagamma.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628055787051 [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