LF

Basic Information

• Brand Name: LF
• Primary DI: 10746190004240
• Version / Model: 844021P
• Company Name: Liebel-Flarsheim Company LLC
• Labeler DUNS: 080186051
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-31
• Public Version: 2
• Public Version Date: 2023-12-04
• Public Version Status: Update
• Public Device Record Key: c1540e06-98d7-4159-91ec-22067e967181

Device Description

CT Syringe with Dual Check Valve Y-Tubing (60”/1500 mm) and Filling Spike; for use with OptiVantage

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
16545	Angiography kit	A collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10746190004240	GS1
Package	20746190004247	GS1	Case	50	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K042744	000

Device Sizes

Type	Value	Unit	Text
Total Volume	200	Milliliter
Pressure	400	Pound per Square Inch
Pressure	2758	KiloPascal