DEVICE: HYDROVEN (05051968031518)
Device Identifier (DI) Information
HYDROVEN
316LI84
In Commercial Distribution
316LI84
HUNTLEIGH HEALTHCARE LIMITED
316LI84
In Commercial Distribution
316LI84
HUNTLEIGH HEALTHCARE LIMITED
84CM LEG INSERT
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? |
---|---|---|---|---|
44768 | Multi-chamber venous compression system garment, reusable |
An inflatable device in the form of a stocking, sleeve, or suit that is applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the sequential inflation of several chambers. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a reusable device.
|
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 |
---|
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 |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
daf91abe-efba-4cef-83dd-758dc1c1f0f2
March 29, 2018
2
August 26, 2016
March 29, 2018
2
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