AMSure ® HG Hydrophilic Intermittent Urethral Catheter HG971616

GUDID 40704411008850

16Fr

AMSINO INTERNATIONAL, INC.

Intermittent urethral drainage catheter, non-antimicrobial, single-use

• Primary Device ID: 40704411008850
• NIH Device Record Key: 13fa9d75-0225-4f1d-84ac-ee7f5b8474bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure ® HG Hydrophilic Intermittent Urethral Catheter
• Version Model Number: 1
• Catalog Number: HG971616
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10704411008859 [Primary]
GS1	40704411008850 [Package]; Contains: 10704411008859; Package: Case [50 Units]; In Commercial Distribution

FDA Product Code

• EZD: Catheter, Straight

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: 2025-07-10
• Device Publish Date: 2025-07-02

On-Brand Devices [AMSure ® HG Hydrophilic Intermittent Urethral Catheter]

• 40704411008850: 16Fr
• 40704411008843: 14Fr
• 40704411008836: 12Fr
• 40704411008829: 10Fr