DEVICE: Neeva Baby (00860005571925)

Device Identifier (DI) Information

Neeva Baby
NB Fetal Doppler 2MHz Mini
In Commercial Distribution

Sebe Inc
00860005571925
GS1

1
204186571 *Terms of Use
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
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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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?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
KNG Monitor, Ultrasonic, Fetal
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

6bfa3cb0-d944-464f-a52e-ed84c1a8d6da
October 26, 2020
1
October 18, 2020
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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)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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