LF

Basic Information

• Brand Name: LF
• Primary DI: 06938327903015
• Version / Model: 100104-A
• Catalog Number: 800099B
• Company Name: Shenzhen Boon Medical Supply Co., Ltd.
• Labeler DUNS: 529174252
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-09
• Public Version: 5
• Public Version Date: 2020-05-11
• Public Version Status: Update
• Public Device Record Key: 6d3e1b7f-d47d-4c7f-96b1-f6dd60b1caee
• Distribution End Date: 9999-12-31

Device Description

200mL CT Syringe with Handi-Fil Straw and Coiled Tube (60"/1500 mm); fits injectors: OptiOne, OptiVantage and CT 9000 ADV

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
15286	Angiographic syringe	A sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26938327903019	GS1	Carton	50	In Commercial Distribution	9999-12-31
Primary	06938327903015	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K182289	000