AMSure® Foley Catheter Tray AS89316S

GUDID 40704411005316

AMSure® Foley Catheter Tray Contents: 2000mL drainage bag, 100% Silicone Foley Catheter, Wrap, Drape, Fenestrated Drape, Catheter Lubricating Jelly Sachet, Nitrile Gloves (2), Forceps, Rayon Balls (5), Povidone-Indine Solution, 10mL Syringe with Pre-filled Sterile Water, Specimen Container, Lid and Label

AMSINO INTERNATIONAL, INC.

Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit

• Primary Device ID: 40704411005316
• NIH Device Record Key: 07270782-4f04-4952-9548-9d6e7bcf9173
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure® Foley Catheter Tray
• Version Model Number: 1
• Catalog Number: AS89316S
• 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	10704411005315 [Primary]
GS1	40704411005316 [Package]; Contains: 10704411005315; Package: Case [10 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® Foley Catheter Tray]

• 40704411005323: AMSure® Foley Catheter Tray Contents: 2000mL drainage bag, 100% Silicone Foley Catheter, Wrap,
• 40704411005316: AMSure® Foley Catheter Tray Contents: 2000mL drainage bag, 100% Silicone Foley Catheter, Wrap,
• 40704411005309: AMSure® Foley Catheter Tray Contents: 2000mL drainage bag, 100% Silicone Foley Catheter, Wrap,
• 40704411003848: AMSure® Foley Catheter Tray Silicone Coated Latex Foley Catheter - 5mL Balloon, Inflate with 10
• 40704411003831: AMSure® Foley Catheter Tray Silicone Coated Latex Foley Catheter - 5mL Balloon, Inflate with 10
• 40704411003824: AMSure® Foley Catheter Tray Silicone Coated Latex Foley Catheter - 5mL Balloon, Inflate with 10