Anasept Antimicrobial Skin and Wound Gel 5015G

GUDID 00367180512151

Anasept® Antimicrobial Skin and Wound Gel is a clear, amorphous hydrogel that helps maintain moist wound environment that is conducive to healing, by either absorbing wound exudate or donating moisture while delivering 0.057% broad spectrum antimicrobial sodium hypochlorite. Anasept® Gel inhibits the growth of microorganisms, 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.

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• Primary Device ID: 00367180512151
• NIH Device Record Key: c4049830-fca4-406f-8a62-18ee6e1a1080
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anasept Antimicrobial Skin and Wound Gel
• Version Model Number: 5015G
• Catalog Number: 5015G
• 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: false
• 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

Device Dimensions

• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 25 degrees C
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 25 degrees C
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 25 degrees C
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 25 degrees C
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 25 degrees C
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 25 degrees C
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 25 degrees C
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 25 degrees C
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 25 degrees C
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 25 degrees C
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 25 degrees C
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 25 degrees C

Device Identifiers

Device Issuing Agency	Device ID
GS1	00367180500158 [Primary]
GS1	00367180512151 [Package]; Contains: 00367180500158; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073547

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-04
• Device Publish Date: 2020-07-27

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

• 00367180512038: Anasept® Antimicrobial Skin and Wound Gel is a clear, amorphous hydrogel that helps maintain mo
• 00367180512151: Anasept® Antimicrobial Skin and Wound Gel is a clear, amorphous hydrogel that helps maintain mo