AMSure® Pre-Connected Urethral Tray

Basic Information

• Brand Name: AMSure® Pre-Connected Urethral Tray
• Primary DI: 10704411007531
• Version / Model: 1
• Catalog Number: AS89216K
• Company Name: AMSINO INTERNATIONAL, INC.
• Labeler DUNS: 825673239
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-28
• Public Version: 2
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 9281e3a9-e169-4dce-8a4b-4968307e577d

Device Description

AMSure® Pre-Connected Urethral Tray 16 Fr. Red Rubber Urethral Catheter Pre-Connected to Drainage Bag CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each 1200 mL Drainage Bag with Pre-Connected 16 Fr. Red Rubber Urethral Catheter 1 each CSR Wrap 1 each Waterproof Absorbent Underpad 1 pair Pre-Cuffed Nitrile Gloves 1 each Fenestrated Drape 1 pack Package Sterile Lubricating Jelly 1 each 2 oz Specimen Container with ID Label NON-STERILE CONTENT: 1 pack BZK Swabsticks (3)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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
47778	Intermittent urethral catheterization kit	A collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories (e.g., gloves, drapes, tray) intended for self-urinary catheterization. The catheter may be repeatedly inserted through the urethra by the user to provide short-term, episodic urine drainage. It is typically pre-lubricated or coated with, made of, or includes materials/substances that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) commonly known as Teflon, or glass]; it might also be coated with or include antimicrobial materials/substances to help prevent infection of the urinary tract. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40704411007532	GS1	case	20	In Commercial Distribution
Primary	10704411007531	GS1