DEVICE: HYDROVEN (05051968031907)
Device Identifier (DI) Information
HYDROVEN
510003
In Commercial Distribution
510003
HUNTLEIGH HEALTHCARE LIMITED
510003
In Commercial Distribution
510003
HUNTLEIGH HEALTHCARE LIMITED
HYDROVEN 3 PUMP USA/CA
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? |
---|---|---|---|---|
16837 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JOW | Sleeve, Limb, Compressible |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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 -25 and 70 Degrees Celsius |
Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9dcf0b85-9b20-4211-8451-c3b42141621b
October 15, 2021
3
August 26, 2016
October 15, 2021
3
August 26, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4402920485885
sales@huntleigh-diagnostics.co.uk
sales@huntleigh-diagnostics.co.uk