LifeFlow Rapid Infusion System FG5001

GUDID 00860000288606

Rapid IV infusion system including handle with sterile tubing set SA5110

410 MEDICAL INNOVATION, LLC

Intravenous administration tubing extension set

• Primary Device ID: 00860000288606
• NIH Device Record Key: 000d0199-0c53-49f3-8dfc-ec57963e3d29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifeFlow Rapid Infusion System
• Version Model Number: FG5001
• Catalog Number: FG5001
• Company DUNS: 050212206
• Company Name: 410 MEDICAL INNOVATION, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000288606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153731

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-30
• Device Publish Date: 2018-10-30

On-Brand Devices [LifeFlow Rapid Infusion System]

• 00860000288606: Rapid IV infusion system including handle with sterile tubing set SA5110
• B355FG50011: Rapid Infusion system including handle and sterile tubing set SA5101