AccessGUDID - DEVICE: Nexodyn Antimicrobial Wound Care Solution (07640158091678)

GUDID

Device Identifier (DI) Information

Brand Name: Nexodyn Antimicrobial Wound Care Solution
Version or Model: 3.5 fl. oz. (100ml) with spray pump
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: APR Applied Pharma Research SA

Primary DI Number: 07640158091678
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482198926 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
59523	Antimicrobial wound irrigation solution	A 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 debridement 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.	Active	false

FDA Product Code

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Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151168	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: NexodynTM 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, Specify: Nexodyn 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, Specify: Special handling precautions are not required if NexodynTM Antimicrobial Wound Care Solution is used in accordance with instructions of the leaflet.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4e95e444-0869-42ee-9618-3f6bf56377e3
Public Version Date: November 28, 2022
Public Version Number: 2
DI Record Publish Date: October 06, 2022