AMSure® PVC Intermittent Catheter

Basic Information

• Brand Name: AMSure® PVC Intermittent Catheter
• Primary DI: 10704411007197
• Version / Model: 1
• Catalog Number: AS861610C
• Company Name: AMSINO INTERNATIONAL, INC.
• Labeler DUNS: 825673239
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-10
• Public Version: 4
• Public Version Date: 2020-06-19
• Public Version Status: Update
• Public Device Record Key: 8e08e00c-acfb-4b49-964b-4a3fce4c7b72

Device Description

AMSure® PVC Intermittent Catheter Male 16" Length Coude Tip

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
EZD	Catheter, Straight	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42433	Intermittent urethral drainage catheter, non-antimicrobial, reusable	A flexible or rigid tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. Because of the potential frequency of catheterization, 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]; it does not include an antimicrobial agent(s). The device may be male or female dedicated. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40704411007198	GS1	Case	20	In Commercial Distribution
Package	30704411007191	GS1	Box	30	In Commercial Distribution
Primary	10704411007197	GS1