Surefire Infusion System

GUDID 00857136004019

120cm, 3.8F Microcatheter with 7.5mm Expandable Tip

SUREFIRE MEDICAL, INC.

Peripheral vascular infusion catheter

• Primary Device ID: 00857136004019
• NIH Device Record Key: 2f1692d6-cafe-449a-af3f-a4ef9fa62fd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surefire Infusion System
• Version Model Number: SHF-38120-LT
• 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
• Length: 120 Centimeter
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.027 Inch
• Outer Diameter: 0.051 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.027 Inch
• Outer Diameter: 0.051 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.027 Inch
• Outer Diameter: 0.051 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.027 Inch
• Outer Diameter: 0.051 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.027 Inch
• Outer Diameter: 0.051 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.027 Inch
• Outer Diameter: 0.051 Inch
• Length: 120 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857136004019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121677

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

Sterilization

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

[00857136004019]

Ethylene Oxide

[00857136004019]

Ethylene Oxide

[00857136004019]

Ethylene Oxide

[00857136004019]

Ethylene Oxide

[00857136004019]

Ethylene Oxide

[00857136004019]

Ethylene Oxide

[00857136004019]

Ethylene Oxide

[00857136004019]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-09
• Device Publish Date: 2016-09-08

On-Brand Devices [Surefire Infusion System]

• 00857136004040: 120cm, 3.8F Microcatheter with 5mm Expandable Tip
• 00857136004019: 120cm, 3.8F Microcatheter with 7.5mm Expandable Tip