DEVICE: DOPPLEX (05051968032089)

Download: XML | JSON

Device Identifier (DI) Information

DOPPLEX
BD3002-USA
BD3002-USA
HUNTLEIGH HEALTHCARE LIMITED
05051968032089
GS1
1
ANTEPARTUM MONITOR USA
CLOSE

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HGM System, Monitoring, Perinatal
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Temperature: between -10 and 40 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Humidity: less than 93 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 860 and 1060 millibar
Storage Environment Atmospheric Pressure: between 860 and 1060 millibar
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
August 22, 2016

CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

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