DEVICE: DOPPLEX (05051968032102)

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Device Identifier (DI) Information

DOPPLEX
BD4000AXS-2/USA
BD4000AXS-2/USA
HUNTLEIGH HEALTHCARE LIMITED
05051968032102
GS1
1
ANTEPARTUM FETAL MONITOR BD4000XS-2/USA
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Cardiotocograph A mains electricity (AC-powered) patient monitor that displays the relationship between maternal labour and the foetal heart rate by means of combining and coordinating uterine contraction and foetal heart monitoring during the perinatal period. The uterine contractions are usually recorded using a tocodynamometer (a pressure transducer) which is strapped onto the mother's abdomen. Commonly known as a tococardiograph or a cardiotocograph (CTG) machine, the heart rate is typically measured with a dedicated ultrasound transducer.
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FDA Product Code

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Product Code Product Code Name
HGM System, Monitoring, Perinatal
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between -10 and 40 Degrees Celsius
Handling Environment Temperature: between -10 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 22, 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
No Package DIs found
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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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No
Yes
No
Yes
No CLOSE

Customer Contact

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