LF

Basic Information

• Brand Name: LF
• Primary DI: 10746190002185
• Version / Model: 801106
• Company Name: Liebel-Flarsheim Company LLC
• Labeler DUNS: 080186051
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 5
• Public Version Date: 2023-12-04
• Public Version Status: Update
• Public Device Record Key: 1585dc34-4d7d-4cb8-bcd4-30a50a0bae39

Device Description

Y-Tubing with Single Check Valve

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: No
• 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
DXT	Injector And Syringe, Angiographic	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44685	Radiographic procedure tubing	A flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30746190002189	GS1	Case	5	In Commercial Distribution
Package	20746190002182	GS1	Dispenser	20	In Commercial Distribution
Primary	10746190002185	GS1

Premarket Submissions

Submission Number	Supplement Number
K984088	000

Device Sizes

Type	Value	Unit	Text
Pressure	1379	KiloPascal
Pressure	200	Pound per Square Inch
Length	60	Inch
Length	152	Centimeter