WOUNDEXPRESS WE100GLX

GUDID 05051968044204

WOUNDEXPRESS IPC GARMENT EXTRA LARGE : SIZE RANGE 60 - 90CM (24 - 35 INCHES)

HUNTLEIGH HEALTHCARE LIMITED

Multi-chamber venous compression system garment, single-use Multi-chamber venous compression system garment, single-use Multi-chamber venous compression system garment, single-use Multi-chamber venous compression system garment, single-use Multi-chamber venous compression system garment, single-use Multi-chamber venous compression system garment, single-use Multi-chamber venous compression system garment, single-use Multi-chamber venous compression system garment, single-use Multi-chamber venous compression system garment, single-use Multi-chamber venous compression system garment, single-use Multi-chamber venous compression system garment, single-use Multi-chamber venous compression system garment, single-use Multi-chamber venous compression system garment, single-use
Primary Device ID05051968044204
NIH Device Record Key58579d64-55ae-47ae-840e-6697959e6929
Commercial Distribution StatusIn Commercial Distribution
Brand NameWOUNDEXPRESS
Version Model NumberWE100GLX
Catalog NumberWE100GLX
Company DUNS217207083
Company NameHUNTLEIGH HEALTHCARE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4402920485885
Emailsales@huntleigh-diagnostics.co.uk
Phone+4402920485885
Emailsales@huntleigh-diagnostics.co.uk
Phone+4402920485885
Emailsales@huntleigh-diagnostics.co.uk
Phone+4402920485885
Emailsales@huntleigh-diagnostics.co.uk
Phone+4402920485885
Emailsales@huntleigh-diagnostics.co.uk
Phone+4402920485885
Emailsales@huntleigh-diagnostics.co.uk
Phone+4402920485885
Emailsales@huntleigh-diagnostics.co.uk
Phone+4402920485885
Emailsales@huntleigh-diagnostics.co.uk
Phone+4402920485885
Emailsales@huntleigh-diagnostics.co.uk
Phone+4402920485885
Emailsales@huntleigh-diagnostics.co.uk
Phone+4402920485885
Emailsales@huntleigh-diagnostics.co.uk
Phone+4402920485885
Emailsales@huntleigh-diagnostics.co.uk
Phone+4402920485885
Emailsales@huntleigh-diagnostics.co.uk

Device Dimensions

Outer Diameter90 Centimeter
Outer Diameter35 Inch
Outer Diameter90 Centimeter
Outer Diameter35 Inch
Outer Diameter90 Centimeter
Outer Diameter35 Inch
Outer Diameter90 Centimeter
Outer Diameter35 Inch
Outer Diameter90 Centimeter
Outer Diameter35 Inch
Outer Diameter90 Centimeter
Outer Diameter35 Inch
Outer Diameter90 Centimeter
Outer Diameter35 Inch
Outer Diameter90 Centimeter
Outer Diameter35 Inch
Outer Diameter90 Centimeter
Outer Diameter35 Inch
Outer Diameter90 Centimeter
Outer Diameter35 Inch
Outer Diameter90 Centimeter
Outer Diameter35 Inch
Outer Diameter90 Centimeter
Outer Diameter35 Inch
Outer Diameter90 Centimeter
Outer Diameter35 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar

Device Identifiers

Device Issuing AgencyDevice ID
GS105051968044204 [Primary]

FDA Product Code

JOWSleeve, Limb, Compressible

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-18
Device Publish Date2023-08-10

On-Brand Devices [WOUNDEXPRESS]

05051968044204WOUNDEXPRESS IPC GARMENT EXTRA LARGE : SIZE RANGE 60 - 90CM (24 - 35 INCHES)
05051968043870WOUNDEXPRESS IPC GARMENT LARGE : SIZE RANGE 50 - 80CM (20 - 31 INCHES)
05051968042941WOUNDEXPRESS IPC PUMP USA
05051968040374WOUNDEXPRESS IPC GARMENT : SIZE RANGE 43 - 77CM (17 - 28 INCHES)

Trademark Results [WOUNDEXPRESS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WOUNDEXPRESS
WOUNDEXPRESS
79325256 not registered Live/Pending
Arjo IP Holding AB
2021-09-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.