AccessGUDID - DEVICE: Anasept Antimicrobial Skin and Wound Gel (00367180500035)

GUDID

Device Identifier (DI) Information

Brand Name: Anasept Antimicrobial Skin and Wound Gel
Version or Model: 5003G
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5003G
Company Name: ANACAPA TECHNOLOGIES, INC.

Primary DI Number: 00367180500035
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 073189370 *Terms of Use

Device Description: Anasept® Antimicrobial Skin and Wound Gel is a clear, amorphous hydrogel that helps maintain moist wound environment that is conducive to healing, by either absorbing wound exudate or donating moisture while delivering 0.057% broad spectrum antimicrobial sodium hypochlorite. Anasept® Gel inhibits the growth of microorganisms, such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens, Acinetobacter baumannii, Clostridium difficile and antibiotic resistant strains such as Methicillin resistant Staphylococcus aureus (MRSA), Vancomycin resistant Enterococcus faecalis (VRE), Carbapenem resistant E.coli (CRE) that are commonly found in wound bed as well as fungi such as Aspergillus niger, Candida albicans and Candida auris.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	Yes
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?
59522	Wound hydrogel dressing, antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K073547	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

[?]

Storage and Handling
Special Storage Condition, Specify: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Weight: 86 Gram

Device Record Status

Public Device Record Key: 1033ad6a-3d15-4d47-aa90-240aea8b0043
Public Version Date: July 28, 2020
Public Version Number: 2
DI Record Publish Date: July 06, 2020