Spanish-Anasept Antimicrobial Skin and Wound cleanser filled in 15 oz. HDPE bott

GUDID 10857278000921

Spanish-Anasept Antimicrobial Skin and Wound cleanser filled in 15 oz. HDPE bottles with dispensing cap

ARGENTUM MEDICAL, LLC

Antimicrobial wound irrigation solution

• Primary Device ID: 10857278000921
• NIH Device Record Key: ea08024f-fe49-4311-a7e3-788a74cc5aa3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spanish-Anasept Antimicrobial Skin and Wound cleanser filled in 15 oz. HDPE bott
• Version Model Number: 4016CS
• Company DUNS: 091449079
• Company Name: ARGENTUM MEDICAL, LLC
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857278000924 [Primary]
GS1	10857278000921 [Package]; Contains: 00857278000924; 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: 2023-06-20
• Device Publish Date: 2023-06-12

Devices Manufactured by ARGENTUM MEDICAL, LLC

• 10653599002251 - Men's Liberty: 2024-06-17 Men's Liberty for iMEDicare, (box of 30)
• 10653599002190 - CathGrip: 2024-06-10 CathGrip Single Strap, Small, Non-Sterile, No Wipes, Brazil
• 10653599002206 - CathGrip: 2024-06-10 CathGrip Double Strap, Large, Non-Sterile, No Wipes, Brazil
• 10653599002213 - CathGrip: 2024-06-10 CathGrip Double Strap, Medium, Non-Sterile, No Wipes, Brazil
• 10653599002220 - CathGrip: 2024-06-10 CathGrip Single Strap, Large, Non-Sterile, No Wipes, Brazil
• 10653599002237 - CathGrip: 2024-06-10 CathGrip Oval, Small, Non-Sterile, No Wipes, Brazil
• 10653599002244 - CathGrip: 2024-06-10 CathGrip Oval, Large, Non-Sterile, No Wipes, Brazil
• 10653599000547 - CathGrip: 2024-04-11 CathGrip Single Strap Large, Non-Sterile, No Alcohol