Anasept Antimicrobial Wound Irrigation Solution

FDA UDI

Class II (US FDA UDI)

by Anacapa Technologies, Inc.

Identity

Trade Name: Anasept Antimicrobial Wound Irrigation Solution FDA UDI
Generic Name: Antimicrobial wound irrigation solution FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 4160IC FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: 4160IC FDA UDI
Primary DI / UDI-DI: 00367180416169 FDA UDI
510(k) Number: K073547 FDA UDI
FDA Product Code: FQH FDA UDI
FRO FDA UDI
GMDN Term: Antimicrobial wound irrigation solution FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5475 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 16 Fluid Ounce FDA UDI

Category: Antimicrobial wound irrigation solution

Anasept Antimicrobial Wound Irrigation Solution by Anacapa Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Antimicrobial wound irrigation solution.

Puracyn® Plus Professional Formula — Innovacyn, Inc. · U
Anasept Antimicrobial Skin and Wound cleanser filled in 12oz. Boston round, HDPE — ARGENTUM MEDICAL, LLC · U
Anasept Antimicrobial Skin and Wound cleanser filled in 4 oz. PET bottles with f — ARGENTUM MEDICAL, LLC · U
ELECTROCYN soma — V3Bio Sdn. Bhd · U
Shield Products — Digital Ally, Inc. · U
ExSept Plus — Angelini Pharma Inc. · Class II
BIAKOS™ Antimicrobial Skin & Wound Cleanser — Sanara Medtech Inc. · U
Prontosan® — B. BRAUN MEDICAL INC. · U

Cleared under the same submission

K073547 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Anacapa Technologies, Inc.

Sources (1)

FDA UDI 9ad6a723-f272-4cae-82b1-c4596459948a 38 fields · synced May 30, 2026