LifeFlow Rapid Infusion System

Basic Information

• Brand Name: LifeFlow Rapid Infusion System
• Primary DI: 00860000288606
• Version / Model: FG5001
• Catalog Number: FG5001
• Company Name: 410 MEDICAL INNOVATION, LLC
• Labeler DUNS: 050212206
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-30
• Public Version: 1
• Public Version Date: 2018-11-30
• Public Version Status: New
• Public Device Record Key: 000d0199-0c53-49f3-8dfc-ec57963e3d29

Device Description

Rapid IV infusion system including handle with sterile tubing set SA5110

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: Yes
• 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
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860000288606	GS1

Premarket Submissions

Submission Number	Supplement Number
K153731	000