AMSure® Foley Catheter Tray AS89318S

GUDID 40704411005323

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

• Primary Device ID: 40704411005323
• NIH Device Record Key: 76ba031a-3ef1-45ef-bdf9-303c50a5a036
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure® Foley Catheter Tray
• Version Model Number: 1
• Catalog Number: AS89318S
• 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	10704411005322 [Primary]
GS1	40704411005323 [Package]; Contains: 10704411005322; 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