TriNav LV Infusion System

GUDID 00857136004224

120cm 0.025" Microcatheter w/ 5.0mm Expandable Tip

SUREFIRE MEDICAL, INC.

Peripheral vascular intervention infusion catheter

• Primary Device ID: 00857136004224
• NIH Device Record Key: 6fb97bb4-5df0-4195-bdc3-40498dc4e726
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriNav LV Infusion System
• Version Model Number: TVM-25120-50
• 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: false
• 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: 0.025 Inch
• Catheter Working Length: 120 Centimeter
• Catheter Gauge: 2.9 French
• Catheter Inner Diameter: 0.025 Inch
• Catheter Working Length: 120 Centimeter
• Catheter Gauge: 2.9 French
• Catheter Inner Diameter: 0.025 Inch
• Catheter Working Length: 120 Centimeter
• Catheter Gauge: 2.9 French
• Catheter Inner Diameter: 0.025 Inch
• Catheter Working Length: 120 Centimeter
• Catheter Gauge: 2.9 French
• Catheter Inner Diameter: 0.025 Inch
• Catheter Working Length: 120 Centimeter
• Catheter Gauge: 2.9 French
• Catheter Inner Diameter: 0.025 Inch
• Catheter Working Length: 120 Centimeter
• Catheter Gauge: 2.9 French
• Catheter Inner Diameter: 0.025 Inch
• Catheter Working Length: 120 Centimeter
• Catheter Gauge: 2.9 French
• Catheter Inner Diameter: 0.025 Inch
• Catheter Working Length: 120 Centimeter
• Catheter Gauge: 2.9 French
• Catheter Inner Diameter: 0.025 Inch
• Catheter Working Length: 120 Centimeter
• Catheter Gauge: 2.9 French
• Catheter Inner Diameter: 0.025 Inch
• Catheter Working Length: 120 Centimeter
• Catheter Gauge: 2.9 French
• Catheter Inner Diameter: 0.025 Inch
• Catheter Working Length: 120 Centimeter
• Catheter Gauge: 2.9 French
• Catheter Inner Diameter: 0.025 Inch
• Catheter Working Length: 120 Centimeter
• Catheter Gauge: 2.9 French
• Catheter Inner Diameter: 0.025 Inch
• Catheter Working Length: 120 Centimeter
• Catheter Gauge: 2.9 French
• Catheter Inner Diameter: 0.025 Inch
• Catheter Working Length: 120 Centimeter
• Catheter Gauge: 2.9 French
• Catheter Inner Diameter: 0.025 Inch
• Catheter Working Length: 120 Centimeter
• Catheter Gauge: 2.9 French
• Catheter Inner Diameter: 0.025 Inch
• Catheter Working Length: 120 Centimeter
• Catheter Gauge: 2.9 French
• Catheter Inner Diameter: 0.025 Inch
• Catheter Working Length: 120 Centimeter
• Catheter Gauge: 2.9 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857136004224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230957

FDA Product Code

• KRA: Catheter, Continuous Flush

Sterilization

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

[00857136004224]

Ethylene Oxide

[00857136004224]

Ethylene Oxide

[00857136004224]

Ethylene Oxide

[00857136004224]

Ethylene Oxide

[00857136004224]

Ethylene Oxide

[00857136004224]

Ethylene Oxide

[00857136004224]

Ethylene Oxide

[00857136004224]

Ethylene Oxide

[00857136004224]

Ethylene Oxide

[00857136004224]

Ethylene Oxide

[00857136004224]

Ethylene Oxide

[00857136004224]

Ethylene Oxide

[00857136004224]

Ethylene Oxide

[00857136004224]

Ethylene Oxide

[00857136004224]

Ethylene Oxide

[00857136004224]

Ethylene Oxide

[00857136004224]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-13
• Device Publish Date: 2023-12-05

On-Brand Devices [TriNav LV Infusion System]

• 00857136004231: 120cm 0.025" Microcatheter w/ 5.0mm Expandable Tip
• 00857136004224: 120cm 0.025" Microcatheter w/ 5.0mm Expandable Tip