DEVICE: Neeva Baby (00860005571925)
Device Identifier (DI) Information
Neeva Baby
NB Fetal Doppler 2MHz Mini
In Commercial Distribution
Sebe Inc
NB Fetal Doppler 2MHz Mini
In Commercial Distribution
Sebe Inc
The Neeva Baby Fetal Doppler Mini is an ultrasonic Doppler that allows expectant mothers and health care professionals to retrieve and listen to the fetal heart
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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34040 | Foetal Doppler system |
A portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability.
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FDA Product Code
[?]Product Code | Product Code Name |
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KNG | Monitor, Ultrasonic, Fetal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6bfa3cb0-d944-464f-a52e-ed84c1a8d6da
October 26, 2020
1
October 18, 2020
October 26, 2020
1
October 18, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined