AMSure® Single Spike Infiltration Tubing IPS001

GUDID 40704411017883

AMSINO INTERNATIONAL, INC.

Surgical irrigation/aspiration tubing set

• Primary Device ID: 40704411017883
• NIH Device Record Key: 4a446030-9a87-4e34-890d-ac6060e7c97c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure® Single Spike Infiltration Tubing
• Version Model Number: 1
• Catalog Number: IPS001
• Company DUNS: 825673239
• Company Name: AMSINO INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10704411017882 [Primary]
GS1	40704411017883 [Package]; Contains: 10704411017882; Package: Case [50 Units]; In Commercial Distribution

FDA Product Code

• KGZ: Accessories, Catheter

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: 2025-07-01
• Device Publish Date: 2025-06-23

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