Anasept Antimicrobial Wound Irrigation Solution - Anasept® Antimicrobial Wound Irrigation Solution - ANACAPA TECHNOLOGIES, INC.

Duns Number:073189370

Device Description: Anasept® Antimicrobial Wound Irrigation Solution is a clear, isotonic liquid that helps in Anasept® Antimicrobial Wound Irrigation Solution is a clear, isotonic liquid that helps in the mechanical removal of the debris from the application site; while delivering 0.057% broad spectrum antimicrobial sodium hypochlorite to the application site via Negative Pressure Wound Therapy Device. Anasept® Antimicrobial Wound Irrigation Solution inhibits the growth of bacteria 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.

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More Product Details

Catalog Number

4160IC

Brand Name

Anasept Antimicrobial Wound Irrigation Solution

Version/Model Number

4160IC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K073547,K073547

Product Code Details

Product Code

FQH

Product Code Name

Lavage, Jet

Device Record Status

Public Device Record Key

9ad6a723-f272-4cae-82b1-c4596459948a

Public Version Date

June 30, 2020

Public Version Number

1

DI Record Publish Date

June 22, 2020

Additional Identifiers

Package DI Number

00367180426168

Quantity per Package

12

Contains DI Package

00367180416169

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"ANACAPA TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6
U Unclassified 3