AMSure® Urethral Self Catheterization Kit AS85014

GUDID 40704411003589

AMSure® Urethral Self Catheterization Kit with RPOLISHED® Eyes, Pre-lubricated, Closed System CONTENTS: 1 Pre-lubricated PVC Urethral Catheter, 16" (40cm) Length, 1 1100ml Collection Bag with Insertion Tip, 3 Povidone-Iodine Swabsticks, 1 Benzalkonium Chloride Prep Pad, 2 Cuffed Vinyl Gloves, 1 Warerproof Underpad, 13" × 18" (340 × 450 mm), 1 Waste Disposal Bag, 1 Gauze Pad, 4" × 4" (100 × 100 mm)

AMSINO INTERNATIONAL, INC.

Intermittent urethral catheterization kit

• Primary Device ID: 40704411003589
• NIH Device Record Key: b21d0980-c499-47b1-862f-f0dc25dc386f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure® Urethral Self Catheterization Kit
• Version Model Number: 1
• Catalog Number: AS85014
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10704411003588 [Primary]
GS1	40704411003589 [Package]; Contains: 10704411003588; Package: Case [50 Units]; In Commercial Distribution

FDA Product Code

• FCM: Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-11-28
• Device Publish Date: 2016-09-23

On-Brand Devices [AMSure® Urethral Self Catheterization Kit]

• 40704411003596: AMSure® Urethral Self Catheterization Kit with RPOLISHED® Eyes, Pre-lubricated, Closed System
• 40704411003589: AMSure® Urethral Self Catheterization Kit with RPOLISHED® Eyes, Pre-lubricated, Closed System
• 40704411003572: AMSure® Urethral Self Catheterization Kit with RPOLISHED® Eyes, Pre-lubricated, Closed System
• 40704411003565: AMSure® Urethral Self Catheterization Kit with RPOLISHED® Eyes, Pre-lubricated, Closed System
• 40704411003558: AMSure® Urethral Self Catheterization Kit with RPOLISHED® Eyes, Pre-lubricated, Closed System