Surefire Spark Infusion System

GUDID 00857136004187

120cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip

SUREFIRE MEDICAL, INC.

Peripheral vascular infusion catheter

• Primary Device ID: 00857136004187
• NIH Device Record Key: 809e872a-fc47-4c52-b90b-e4bce81793e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surefire Spark Infusion System
• Version Model Number: SPARK-A120
• 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

• 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
• Lumen/Inner Diameter: 0.021 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857136004187 [Primary]

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

Sterilization

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

[00857136004187]

Ethylene Oxide

[00857136004187]

Ethylene Oxide

[00857136004187]

Ethylene Oxide

[00857136004187]

Ethylene Oxide

[00857136004187]

Ethylene Oxide

[00857136004187]

Ethylene Oxide

[00857136004187]

Ethylene Oxide

[00857136004187]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-25
• Device Publish Date: 2019-09-17

On-Brand Devices [Surefire Spark Infusion System]

• 00857136004163: 150cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip
• 00857136004187: 120cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip