Anasept Antimicrobial Wound Irrigation Solution 4160IC

GUDID 00367180426168

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.

ANACAPA TECHNOLOGIES, INC.

Antimicrobial wound irrigation solution, non-sterile
Primary Device ID00367180426168
NIH Device Record Key9ad6a723-f272-4cae-82b1-c4596459948a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnasept Antimicrobial Wound Irrigation Solution
Version Model Number4160IC
Catalog Number4160IC
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9093947795
Emailanacapa@anacapa-tech.net
Phone9093947795
Emailanacapa@anacapa-tech.net
Phone9093947795
Emailanacapa@anacapa-tech.net
Phone9093947795
Emailanacapa@anacapa-tech.net
Phone9093947795
Emailanacapa@anacapa-tech.net
Phone9093947795
Emailanacapa@anacapa-tech.net
Phone9093947795
Emailanacapa@anacapa-tech.net
Phone9093947795
Emailanacapa@anacapa-tech.net
Phone9093947795
Emailanacapa@anacapa-tech.net
Phone9093947795
Emailanacapa@anacapa-tech.net
Phone9093947795
Emailanacapa@anacapa-tech.net
Phone9093947795
Emailanacapa@anacapa-tech.net

Device Dimensions

Total Volume16 Fluid Ounce
Total Volume16 Fluid Ounce
Total Volume16 Fluid Ounce
Total Volume16 Fluid Ounce
Total Volume16 Fluid Ounce
Total Volume16 Fluid Ounce
Total Volume16 Fluid Ounce
Total Volume16 Fluid Ounce
Total Volume16 Fluid Ounce
Total Volume16 Fluid Ounce
Total Volume16 Fluid Ounce
Total Volume16 Fluid Ounce

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.

Device Identifiers

Device Issuing AgencyDevice ID
GS100367180416169 [Primary]
GS100367180426168 [Package]
Contains: 00367180416169
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 Date2020-06-30
Device Publish Date2020-06-22

Devices Manufactured by ANACAPA TECHNOLOGIES, INC.

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