Anasept Antimicrobial Skin and Wound Cleanser 4004SC

GUDID 00367180400441

Anasept® Antimicrobial Skin and Wound Cleanser 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. Anasept® also 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.

ANACAPA TECHNOLOGIES, INC.

Antimicrobial wound irrigation solution, non-sterile
Primary Device ID00367180400441
NIH Device Record Key760b4847-d181-4e63-9523-c16f871d21ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnasept Antimicrobial Skin and Wound Cleanser
Version Model Number4004SC
Catalog Number4004SC
Company DUNS073189370
Company NameANACAPA TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net
Phone909-394-7795
Emailanacapa@anacapa-tech.net

Device Dimensions

Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce
Total Volume4 Fluid Ounce

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 25 degrees C, DO NOT FREEZE

Device Identifiers

Device Issuing AgencyDevice ID
GS100367180400441 [Primary]
GS100367180412444 [Package]
Package: Case [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FQHLavage, Jet

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-07
Device Publish Date2020-08-28

On-Brand Devices [Anasept Antimicrobial Skin and Wound Cleanser]

00367180412802Anasept® Antimicrobial Skin and Wound Cleanser is a clear, isotonic liquid that helps in the me
00367180412086Anasept® Antimicrobial Skin and Wound Cleanser is a clear, isotonic liquid that helps in the me
00367180412123Anasept® Antimicrobial Skin and Wound Cleanser is a clear, isotonic liquid that helps in the me
00367180412161Anasept® Antimicrobial Skin and Wound Cleanser is a clear, isotonic liquid that helps in the me
00367180400045Anasept® Antimicrobial Skin and Wound Cleanser is a clear, isotonic liquid that helps in the me
00367180400441Anasept® Antimicrobial Skin and Wound Cleanser is a clear, isotonic liquid that helps in the me
00367180412888Anasept® Antimicrobial Skin and Wound Cleanser is a clear, isotonic liquid that helps in the me

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.