AMSure® Sterile Water for lrrigation USP 1000 mL AS-6491

GUDID 40704411020531

AMSINO INTERNATIONAL, INC.

Wound irrigation sterile water

• Primary Device ID: 40704411020531
• NIH Device Record Key: da834635-e13e-4e4a-9a7e-3f9bd7efc386
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure® Sterile Water for lrrigation USP 1000 mL
• Version Model Number: 1
• Catalog Number: AS-6491
• Company DUNS: 825673239
• Company Name: AMSINO INTERNATIONAL, 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: false
• 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	00704411020533 [Primary]
GS1	40704411020531 [Package]; Contains: 00704411020533; Package: Case [9 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083042

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: 2025-12-15
• Device Publish Date: 2025-12-05

Devices Manufactured by AMSINO INTERNATIONAL, INC.

• 40704411020241 - AMSure® 0.9% Sodium Chloride lrrigation USP 100 mL, Sterile: 2025-12-15
• 40704411020258 - AMSure® Sterile Water for lrrigation USP 100 mL: 2025-12-15
• 00704411020267 - AMSure® Sterile Water for lrrigation USP 250 mL: 2025-12-15
• 40704411020272 - AMSure® 0.9% Sodium Chloride lrrigation USP 250 mL, Sterile: 2025-12-15
• 40704411020500 - AMSure® 0.9% Sodium Chloride lrrigation USP 500 mL, Sterile: 2025-12-15
• 40704411020517 - AMSure® Sterile Water for lrrigation USP 500 mL: 2025-12-15
• 40704411020524 - AMSure® 0.9% Sodium Chloride lrrigation USP 1000 mL, Sterile: 2025-12-15
• 40704411020531 - AMSure® Sterile Water for lrrigation USP 1000 mL: 2025-12-15
• 40704411020531 - AMSure® Sterile Water for lrrigation USP 1000 mL: 2025-12-15