AMSure ® Add-A-Foley Tray

Basic Information

• Brand Name: AMSure ® Add-A-Foley Tray
• Primary DI: 10704411014706
• Version / Model: 1
• Catalog Number: AS89830
• Company Name: AMSINO INTERNATIONAL, INC.
• Labeler DUNS: 825673239
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-29
• Public Version: 1
• Public Version Date: 2022-04-06
• Public Version Status: New
• Public Device Record Key: 1141ba4d-3e5d-4555-9890-7bb2ffe47490
• Distribution End Date: 2022-03-31

Device Description

400mL Urine Meter attached to 2600mL Drainage Bag (China) with: Universal hook hanger Bed sheet clamp T-valve drainage outlet Air vent AMSafe® needleless sampling port 30 mL Pre-Filled Syringe with Sterile Water (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
64266	Intermittent urethral drainage catheter, non-antimicrobial, single-use	A flexible or rigid tube designed for a single insertion into the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide urine drainage, typically for an individual who is physiologically incapable of voiding. The device is typically pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass] and is disposed of after use; it does not include an antimicrobial agent(s). The device may be male or female dedicated. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10704411014706	GS1