Aspiration and Flush Assembly

Basic Information

• Brand Name: Aspiration and Flush Assembly
• Primary DI: 00817640020110
• Version / Model: AFA-LL
• Catalog Number: AFA-LL
• Company Name: URESIL, LLC
• Labeler DUNS: 192559557
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-19
• Public Version: 1
• Public Version Date: 2022-05-27
• Public Version Status: New
• Public Device Record Key: f6bacc65-6e5d-4fcf-b4af-55426da4ab9b

Device Description

ASPIRATION FLUSH ADAPTER – LUER LOCK SYSTEM

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: Yes
• 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
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60538	Luer/Luer linear connector, single-use	A small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10817640020117	GS1	Dispenser	5	In Commercial Distribution
Primary	00817640020110	GS1
Package	20817640020114	GS1	Shipper	5	In Commercial Distribution
Previous	H862AFALL0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]