DEVICE: DOPPLEX (05051968025265)

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Device Record History
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Device Identifier (DI) Information
DOPPLEX
SONICAIDONE
In Commercial Distribution
SONICAIDONE
HUNTLEIGH HEALTHCARE LIMITED
05051968025265
GS1

1
217207083 *Terms of Use
SONICAID ONE
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

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?
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

[?]
Product Code Product Code Name
HGL Transducer, Ultrasonic, Obstetric
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K023618 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Temperature: between -10 and 60 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar
Storage Environment Atmospheric Pressure: between 500 and 1060 millibar
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
cb02b401-3f48-4a6e-a06d-f9ba76b2a5f7
July 06, 2018
3
August 25, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+4402920485885
sales@huntleigh-diagnostics.co.uk
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