AMSure ® Four Lead Bladder Irrigation Set

Basic Information

• Brand Name: AMSure ® Four Lead Bladder Irrigation Set
• Primary DI: 10704411016090
• Version / Model: 1
• Catalog Number: ABL404
• Company Name: AMSINO INTERNATIONAL, INC.
• Labeler DUNS: 825673239
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-13
• Public Version: 1
• Public Version Date: 2023-04-21
• Public Version Status: New
• Public Device Record Key: ec35d2f4-6c4b-4174-8c3c-7367f325c8ce
• Distribution End Date: 2023-04-20

Device Description

90" ( 2286mm) Overall Length/0.27" (6.8mm) I.D.

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
LJH	System, Irrigation, Urological	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14301	Urological irrigation set	A collection of sterile items intended to be used for the infusion of fluids used to flush the urethra and bladder. It typically includes tubing, connectors, a syringe, a roller clamp and other items used for flushing or continuous irrigation in procedures such as a cystoscopy or transurethral resection (TUR). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40704411016091	GS1	case	20	Not in Commercial Distribution	2023-04-13
Primary	10704411016090	GS1