AccessGUDID - DEVICE: NeilMed Wound Wash (00705928652101)

GUDID

Device Identifier (DI) Information

Brand Name: NeilMed Wound Wash
Version or Model: WoundWash
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WW-0NB-48-ENU-USL
Company Name: NEILMED PHARMACEUTICALS, INC.

Primary DI Number: 00705928652101
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 799295915 *Terms of Use

Device Description: NeilMed Wound Wash - Sterile Saline Solution Ready to Use Isotonic-Drug Free-Preservative Free

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64871	Non-antimicrobial wound irrigation solution, saline	A solution of sodium chloride (NaCl), without additional compounds (i.e., not a multiple solute solution), intended to be used to irrigate and clean a wound, wound dressing, or surgical site; it may in addition be intended for non-patient-contact applications (e.g., device irrigation). It is not intended to provide antimicrobial activity and may be supplied in a plastic container with a spray nozzle; it is intended to be used in the home or healthcare facility. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123910	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Temperature: between 5 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 177.6 Gram

Device Record Status

Public Device Record Key: 78587950-2a62-4f6b-b77e-163b013d7a05
Public Version Date: November 28, 2022
Public Version Number: 3
DI Record Publish Date: August 28, 2020