LF

Basic Information

• Brand Name: LF
• Primary DI: 10746190002222
• Version / Model: 810551
• Company Name: Liebel-Flarsheim Company LLC
• Labeler DUNS: 080186051
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-07
• Public Version: 5
• Public Version Date: 2023-12-04
• Public Version Status: Update
• Public Device Record Key: bf249ae1-04b8-4891-bb57-d08dc7ed8701

Device Description

Transfer Set

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
43324	Fluid transfer set, general-purpose	A collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20746190002229	GS1	Case	50	In Commercial Distribution
Primary	10746190002222	GS1

Premarket Submissions

Submission Number	Supplement Number
K042744	000

Device Sizes

Type	Value	Unit	Text
Pressure	138	KiloPascal
Pressure	20	Pound per Square Inch