BIATAIN 378039980

GUDID 05032749034461

14-24AP Silver Alginate II

ADVANCED MEDICAL SOLUTIONS LIMITED

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 05032749034461
• NIH Device Record Key: 63fa7c53-bfb4-46b0-a705-e9a6b8dffd07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIATAIN
• Version Model Number: Alginate Ag
• Catalog Number: 378039980
• Company DUNS: 770434090
• Company Name: ADVANCED MEDICAL SOLUTIONS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05032749034461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090453

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [BIATAIN]

• 05032749034461: 14-24AP Silver Alginate II
• 05032749034454: 14-24AP Silver Alginate II
• 05032749034447: 14-24AP Silver Alginate II
• 05032749034430: 14-24AP Silver Alginate II
• 05032749033419: 14-24AP Silver Alginate II
• 05032749031712: 14-24AP Silver Alginate II
• 05032749031200: 14-24AP Silver Alginate II
• 05032749030241: 14-2AP Alginate Rope
• 05032749029337: 14-2AP
• 05032749028347: 14-2AP
• 05032749027579: 14-2AP