Bard® Ellik Bladder Evacuator (Reservoir Only)

Basic Information

• Brand Name: Bard® Ellik Bladder Evacuator (Reservoir Only)
• Primary DI: 10801741080798
• Version / Model: 0450A
• Catalog Number: 0450A
• Company Name: C. R. Bard, Inc.
• Labeler DUNS: 016898496
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 121c695c-48cf-4b1b-90c5-17a6c5d84807

Device Description

Bard® Ellik Bladder Evacuator (Reservoir Only)

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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KQT	EVACUATOR, GASTRO-UROLOGY	Gastroenterology, Urology	876.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48179	Bladder evacuator, single-use	A sterile, 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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10801741080798	GS1
Unit of Use	00801741080791	GS1

Customer Contacts

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