DEVICE: DOPPLEX (05051968032058)

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Device Identifier (DI) Information

DOPPLEX
D900-DATA/C

HUNTLEIGH HEALTHCARE LIMITED
05051968032058
GS1
1
D900 DATASCOPE
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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
Noninvasive vascular ultrasound system, battery-powered A hand-held, battery-powered device assembly consisting of a graphical display unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. Clinical applications include venous/arterial flow screening (e.g., assessment of air embolism, atherosclerosis, varicose veins, venous thrombosis, and the vascular states of partially severed extremities), ankle pressure index, and/or blood flow wave form recording.
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FDA Product Code

[?]
Product Code Product Code Name
KNG Monitor, Ultrasonic, Fetal
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Sterilization

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

[?]
Storage and Handling
Storage Environment Atmospheric Pressure: between 860 and 1060 millibar
Handling Environment Atmospheric Pressure: between 860 and 1060 millibar
Storage Environment Humidity: less than 93 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
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

[?]
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

[?]
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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