Nexodyn Antimicrobial Wound Care Solution

Primary DI
07640158091678
Brand
Nexodyn Antimicrobial Wound Care Solution
Company
APR Applied Pharma Research SA
Model
3.5 fl. oz. (100ml) with spray pump
Published
2022-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151168000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151168000Nexodyn AOS Wound Care SolutionApr Applied Pharma Research SA2015-12-22FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640158091678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640158091678076401580916787640158091678

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial wound irrigation solution, non-sterileA non-sterile solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridment and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Nexodyn Antimicrobial wound Care Solution is not-flammable. Special storage precautions are not needed. After use, the container should be secured with the screw cap or, if the spray pump is fitted
Special Storage Condition, Specify00NexodynTM Antimicrobial Wound Care Solution should be stored in a dry place, protected from sunlight and heat, in its original sealed bottle and carton between 41 °F and 77 °F (5 °C and 25 °C).
Special Storage Condition, Specify00Special handling precautions are not required if NexodynTM Antimicrobial Wound Care Solution is used in accordance with instructions of the leaflet.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
482198926
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
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00852009002451Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
09551012610479ELECTROCYN somaV3BIO SDN. BHD.FRO2026-07-16
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00850088144628CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
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00850019138511SilverSealNEXGEL Inc.FRO2026-07-08
00850067990086Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
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00850067990260Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990352Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
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00850067990536Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990628Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990710Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06