AMSure® Add-A-Foley Catheter Tray AS89300

GUDID 40704411005293

AMSure® Add-A-Foley Catheter Tray CONTENTS; 1 2000mL Drainage bag, 1 Wrap, 1 Drape, 2 Nitrile Gloves, 1 Fenestrate Drape, 1 Pkg. Povidone-Iodine Solution, 5 Rayon Balls, 1 Catheter Lubricating Jelly Sachet, 1 Plastic Forceps, 1 Specimen Container and Label, 1 10mL Syringe with Pre-filled Sterile Water

AMSINO INTERNATIONAL, INC.

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• Primary Device ID: 40704411005293
• NIH Device Record Key: 083d28f1-9ca1-4164-8d37-c0cb59eb95f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure® Add-A-Foley Catheter Tray
• Version Model Number: 1
• Catalog Number: AS89300
• 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	10704411005292 [Primary]
GS1	40704411005293 [Package]; Contains: 10704411005292; 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® Add-A-Foley Catheter Tray]

• 40704411007242: AMSure® Add-A-Foley Catheter Tray CONTENTS: One each 2000 mL Drainage bag with: Large anti-refl
• 40704411005293: AMSure® Add-A-Foley Catheter Tray CONTENTS; 1 2000mL Drainage bag, 1 Wrap, 1 Drape, 2 Nitrile G