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.

• 00857136004224 - TriNav LV Infusion System: 2023-12-13 120cm 0.025" Microcatheter w/ 5.0mm Expandable Tip
• 00857136004231 - TriNav LV Infusion System: 2023-12-13 120cm 0.025" Microcatheter w/ 5.0mm Expandable Tip
• 00857136004194 - TriSalus Infusion System: 2020-02-10120cm, 0.021" Microcatheter with 6mm Expandable Tip
• 00857136004194 - TriSalus Infusion System: 2020-02-10 120cm, 0.021" Microcatheter with 6mm Expandable Tip
• 00857136004200 - TriNav Infusion System: 2020-01-09 150cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip
• 00857136004217 - TriNav Infusion System: 2020-01-09 120cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip
• 00857136004187 - Surefire Spark Infusion System: 2019-09-25 120cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip
• 00857136004170 - SIS Adaptor: 2019-06-07 Surefire Infusion System Adaptor
• 00857136004019 - Surefire Infusion System: 2019-04-09 120cm, 3.8F Microcatheter with 7.5mm Expandable Tip