Anasept Antimicrobial Skin and Wound Cleanser 4012SC

GUDID 00367180412123

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 Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution

• Primary Device ID: 00367180412123
• NIH Device Record Key: bae9f8fb-1b02-48c1-8499-36007ea8d074
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anasept Antimicrobial Skin and Wound Cleanser
• Version Model Number: 4012SC
• Catalog Number: 4012SC
• Company DUNS: 073189370
• Company Name: ANACAPA TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net

Device Dimensions

• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce
• Total Volume: 12 Fluid Ounce

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00367180400120 [Primary]
GS1	00367180412123 [Package]; Contains: 00367180400120; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073547

FDA Product Code

• FQH: Lavage, Jet

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-07-28
• Device Publish Date: 2020-06-08

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

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