TriNav FLX Infusion System

GUDID 00857136004286

150cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip

SUREFIRE MEDICAL, INC.

Peripheral vascular intervention infusion catheter

• Primary Device ID: 00857136004286
• NIH Device Record Key: cd3fb462-2dfc-42d8-8e27-63a977d4881b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriNav FLX Infusion System
• Version Model Number: FLX-21150-35
• Company DUNS: 832575497
• Company Name: SUREFIRE MEDICAL, INC.
• 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 Dimensions

• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 2.4 French
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 2.4 French
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 2.4 French
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 2.4 French
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 2.4 French
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 150 Centimeter
• Catheter Gauge: 2.4 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857136004286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180677

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

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: 2025-04-23
• Device Publish Date: 2025-04-15

On-Brand Devices [TriNav FLX Infusion System]

• 00857136004286: 150cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip
• 00857136004279: 120cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip