AMSure® Foley Catheter Tray

Basic Information

• Brand Name: AMSure® Foley Catheter Tray
• Primary DI: 10704411019718
• Version / Model: 1
• Catalog Number: AS89918H
• Company Name: AMSINO INTERNATIONAL, INC.
• Labeler DUNS: 825673239
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-01
• Public Version: 1
• Public Version Date: 2025-07-09
• Public Version Status: New
• Public Device Record Key: 06b03690-dd8f-479b-8b2b-2b90d1c0fdf2

Device Description

"•Hydrophilic Latex Foley Catheter (sterilized using ethylene oxide) (China) •FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestrated Drape (sterilized using ethylene oxide) (China) •Catheter Lubricating Jelly Sachet 5g (sterilized using irradiation) (USA) •Nitrile Gloves (2)(sterilized using ethylene oxide) (China) •Forceps (sterilized using ethylene oxide) (China) •benzalkonium Chloride Prep Pad (non-sterile) (USA) •10 mL Pre-filled Syringe with Sterile Water (sterilized using irradiation) (China) •Specimen Container, Lid and Label (sterilized using ethylene oxide) (China)"

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32031	Indwelling urethral catheterization kit, adult	A collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40704411019719	GS1	Case	10	In Commercial Distribution
Primary	10704411019718	GS1