TriSalus Infusion System

GUDID 00857136004194

120cm, 0.021" Microcatheter with 6mm Expandable Tip

SUREFIRE MEDICAL, INC.

Peripheral vascular infusion catheter

• Primary Device ID: 00857136004194
• NIH Device Record Key: c4d3f776-d193-4bbc-a209-ab375c4619c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriSalus Infusion System
• Version Model Number: TIS-21120-60
• 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

• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Length: 120 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857136004194 [Primary]

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

Sterilization

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

[00857136004194]

Ethylene Oxide

[00857136004194]

Ethylene Oxide

[00857136004194]

Ethylene Oxide

[00857136004194]

Ethylene Oxide

[00857136004194]

Ethylene Oxide

[00857136004194]

Ethylene Oxide

[00857136004194]

Ethylene Oxide

[00857136004194]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-10
• Device Publish Date: 2020-01-31

Devices Manufactured by SUREFIRE MEDICAL, INC.

• 00857136004330 - TriGuide Guiding Catheter: 2025-12-04 65cm 0.058" ID 6F Guide Catheter w/ Axis Shape
• 00857136004347 - TriGuide Guiding Catheter: 2025-12-04 65cm 0.058" ID 6F Guide Catheter w/ Sim1 Shape
• 00857136004354 - TriGuide Guiding Catheter: 2025-12-04 65cm 0.058" ID 6F Guide Catheter w/ Cobra Shape
• 00857136004316 - TriNav XP Infusion System: 2025-10-07 130cm 0.025" Microcatheter w/ 3.5mm Expandable Tip
• 00857136004323 - TriNav XP Infusion System: 2025-10-07 150cm 0.025" Microcatheter w/ 3.5mm Expandable Tip
• 00857136004279 - TriNav FLX Infusion System: 2025-04-23 120cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip
• 00857136004286 - TriNav FLX Infusion System: 2025-04-23 150cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip
• 00857136004248 - TriGuide Guiding Catheter: 2024-08-19 TriSalus TriGuide Guiding Catheter, 5F, Axis Shape, 0.048" ID, 65cm Usable Length