ELMED INCORPORATED

Basic Information

• Brand Name: ELMED INCORPORATED
• Primary DI: 00198506072857
• Version / Model: 31430-02
• Catalog Number: 31430-02
• Company Name: ELMED INCORPORATED
• Labeler DUNS: 049290364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-28
• Public Version: 1
• Public Version Date: 2024-11-05
• Public Version Status: New
• Public Device Record Key: 0ca7ba44-7423-4ad0-b449-e3a4edfa53f1

Device Description

ELLIK EVACUATOR ADAPTER FOR CONNECTING TOOMEY SYRINGE TO SHEATH

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37143	Bladder evacuator, reusable	A hand-operated device that is attached to a resectoscope and used to suction tissue and body fluids that are released during a transurethral resection (TUR) procedure. It typically consists of a glass or plastic container, a squeeze bulb, tubing and a connector/adaptor for connection to the resectoscope. It is filled with sterile water and vigorously squeezed to force the water through the resectoscope to irrigate and evacuate tissue fragments, blood clots, or calculi from the urinary bladder; these are caught and trapped within the evacuator so as not to be returned to the bladder when the device is squeezed again. Commonly known as an Ellik evacuator. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00198506072857	GS1

Customer Contacts

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