DEVICE: HYDROVEN (05051968031211)
Device Identifier (DI) Information
HYDROVEN
5101L84
In Commercial Distribution
5101L84
HUNTLEIGH HEALTHCARE LIMITED
5101L84
In Commercial Distribution
5101L84
HUNTLEIGH HEALTHCARE LIMITED
LEG ASSY 84CM HYDROVEN 1
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? |
---|---|---|---|---|
30877 | Single-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 intermittent inflation of a single-chamber. 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 -25 and 70 Degrees Celsius |
Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
98031e01-586c-49db-a242-616b53aefd2d
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