SIS Adaptor

GUDID 00857136004170

Surefire Infusion System Adaptor

SUREFIRE MEDICAL, INC.

Frame/rail/pole device holder

• Primary Device ID: 00857136004170
• NIH Device Record Key: 119057c2-8fc7-49e3-a63f-c70f19fc4e3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIS Adaptor
• Version Model Number: STA-0001
• Company DUNS: 832575497
• Company Name: SUREFIRE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00857136004170 [Primary]

FDA Product Code

• FOX: Stand, Infusion

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-02-20

Devices Manufactured by SUREFIRE MEDICAL, INC.

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• 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
• 00857136004255 - TriGuide Guiding Catheter: 2024-08-19 TriSalus TriGuide Guiding Catheter, 5F, Simmons 1 (SIM1) Shape, 0.048" ID, 65cm Usable Length
• 00857136004262 - TriGuide Guiding Catheter: 2024-08-19 TriSalus TriGuide Guiding Catheter, 5F, Cobra Shape, 0.048" ID, 65cm Usable Length
• 00857136004224 - TriNav LV Infusion System: 2023-12-13 120cm 0.025" Microcatheter w/ 5.0mm Expandable Tip