Surefire Precision Infusion System

GUDID 00857136004088

120cm, 0.021" Microcatheter with 3.5mm Expandable Tip

SUREFIRE MEDICAL, INC.

Peripheral vascular infusion catheter

• Primary Device ID: 00857136004088
• NIH Device Record Key: a2459642-842c-44b2-b20c-722bdbb42e71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surefire Precision Infusion System
• Version Model Number: SPS-21120-35
• 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 Gauge: 3.2 French
• Catheter Gauge: 3.2 French
• Catheter Gauge: 3.2 French
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Catheter Gauge: 3.2 French
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Catheter Gauge: 3.2 French
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Catheter Gauge: 3.2 French
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Catheter Gauge: 3.2 French
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Catheter Gauge: 3.2 French
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.021 Inch
• Catheter Gauge: 3.2 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857136004088 [Primary]

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

Sterilization

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

[00857136004088]

Ethylene Oxide

[00857136004088]

Ethylene Oxide

[00857136004088]

Ethylene Oxide

[00857136004088]

Ethylene Oxide

[00857136004088]

Ethylene Oxide

[00857136004088]

Ethylene Oxide

[00857136004088]

Ethylene Oxide

[00857136004088]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-09
• Device Publish Date: 2016-09-08

On-Brand Devices [Surefire Precision Infusion System]

• 00857136004132: 150cm 0.025" Microcatheter w/ 5mm Expandable Tip
• 00857136004125: 150cm 0.025" Microcatheter w/ 7mm Expandable Tip
• 00857136004118: 120cm 0.025" Microcatheter w/ 7mm Expandable Tip
• 00857136004101: 120cm 0.025" Microcatheter w/ 5mm Expandable Tip
• 00857136004095: 150cm 0.021" Microcatheter w/ 3.5mm Expandable Tip
• 00857136004088: 120cm, 0.021" Microcatheter with 3.5mm Expandable Tip