DryMax BORDER F50514/10

GUDID 17350031912385

Superabsorbent dressing

Absorbest AB

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Primary Device ID17350031912385
NIH Device Record Key7044f76b-45be-4c22-bc24-c6983553e45a
Commercial Distribution StatusIn Commercial Distribution
Brand NameDryMax BORDER
Version Model NumberF50514/10
Catalog NumberF50514/10
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

Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter
Length15 Centimeter
Width15 Centimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107350031912388 [Primary]
GS117350031912385 [Unit of Use]

FDA Product Code

NACDressing, wound, hydrophilic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

Ethylene Oxide


[17350031912385]

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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