DEVICE: Ultrasonic Pocket Doppler (06944413800168)

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Device Record History
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Device Identifier (DI) Information
Ultrasonic Pocket Doppler
SONOTRAX Ⅱ
In Commercial Distribution

Edan Instruments, Inc.
06944413800168
GS1

1
529173163 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
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No
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Yes
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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
HEP Monitor, Blood-Flow, Ultrasonic
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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
67a2f6c3-3f4f-43e7-aa9e-8ec7b3ab108b
March 29, 2018
2
September 01, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
6944413802421 10 06944413800168 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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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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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
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Customer Contact

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No Customer Contact currently defined
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