DryMax BORDER F50515/10

GUDID 17350031912545

Superabsorbent dressing

Absorbest AB

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Primary Device ID17350031912545
NIH Device Record Key6285622c-8080-4d8c-a554-a22a4c02f57f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDryMax BORDER
Version Model NumberF50515/10
Catalog NumberF50515/10
Company DUNS631758273
Company NameAbsorbest AB
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter
Width10 Centimeter
Length20 Centimeter

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107350031912548 [Primary]
GS117350031912545 [Unit of Use]

FDA Product Code

NACDressing, wound, hydrophilic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


[17350031912545]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-24
Device Publish Date2022-11-16

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