LF

Basic Information

• Brand Name: LF
• Primary DI: 10746190002383
• Version / Model: 335563
• Company Name: Liebel-Flarsheim Company LLC
• Labeler DUNS: 080186051
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-10
• Public Version: 3
• Public Version Date: 2022-01-05
• Public Version Status: Update
• Public Device Record Key: 67ea0b30-9ae3-446f-8067-894b60e6c10b

Device Description

Drain Bag used with Hydra Vision or Direct Digital Urology Systems

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KQS	Table, Cystometric, Non-Electric And Accessories	Gastroenterology, Urology	876.4890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33254	Urological operating table, electrohydraulic	A mobile, mains electricity (AC-powered) hydraulic-mechanism table designed to support a patient during urological examination and surgical procedures, including cystoscopic procedures and both transurethral and open surgery of the urinary tract. Commonly known as a transurethral resection (TUR) table, its surface consists of a flat section with a headrest; it includes adjustable leg holders/stirrups either directly attached to the table or to its side rails. It may also include traction handles and an integrated urine/irrigation fluid collection tray with a filter to catch urinary stones and/or stone fragments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20746190002380	GS1	Case	10	In Commercial Distribution
Primary	10746190002383	GS1