DEVICE: HYDROVEN (05051968032362)

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Device Identifier (DI) Information

HYDROVEN
316003US
316003US
HUNTLEIGH HEALTHCARE LIMITED
05051968032362
GS1
1
HYDROVEN 12 PUMP 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
Sequential venous compression system A system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by applying sequential pressure to a patient's legs to promote venous blood flow. It consists of a compression pump, control/timing mechanism, tubing and has pneumatic stockings, sleeves, or a suit with several chambers that inflate and deflate sequentially in a pattern beginning at the foot or ankle and continuing to chambers around the calf and thigh. In some systems, each chamber reaches the same pressure but at different times, while others apply greater pressure distally which gradually diminishes higher up.
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FDA Product Code

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Product Code Product Code Name
JOW Sleeve, Limb, Compressible
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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 Atmospheric Pressure: between 500 and 1060 millibar
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar
Storage Environment Humidity: between 20 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 20 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Handling Environment Temperature: between 5 and 40 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 26, 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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