SmartFlow NGS-NC-04

GUDID 00850359007045

Smart Flow Neuro Ventricular Cannula, 14 ga, .021” ID x 10 ft x 15mm tip

MRI INTERVENTIONS, INC.

Vascular microcatheter

• Primary Device ID: 00850359007045
• NIH Device Record Key: a09c6fd4-7431-4635-b653-f2ea39a24a6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartFlow
• Version Model Number: NGS-NC-04
• Catalog Number: NGS-NC-04
• Company DUNS: 959181160
• Company Name: MRI INTERVENTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 949-900-6833
• Email: info@mriinterventions.com

Device Dimensions

• Length: 10 Feet
• Lumen/Inner Diameter: 0.021 Inch
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850359007045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102101

FDA Product Code

• HCD: Cannula, Ventricular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2016-08-12

On-Brand Devices [SmartFlow]

• 00850359007049: Smart Flow Neuro Ventricular Cannula, 14ga, .021 ID x 10 ft x 10mm tip (short)
• 00850359007048: Smart Flow Neuro Ventricular Cannula, 14ga, .021 ID x 10 ft x 10mm tip
• 00850359007047: Smart Flow Neuro Ventricular Cannula, 16ga, .008 ID x 10 ft x 10mm tip
• 00850359007046: Smart Flow Neuro Ventricular Cannula, 16ga, .008 ID x 10 ft x 12mm tip
• 00850359007045: Smart Flow Neuro Ventricular Cannula, 14 ga, .021” ID x 10 ft x 15mm tip
• 00850359007044: Smart Flow Neuro Ventricular Cannula, 14 ga, .021” ID x 4 ft x 15mm tip
• 00850359007043: Smart Flow Neuro Ventricular Cannula, 16 ga, .008” ID x 10 ft x 15mm tip
• 00850359007042: Smart Flow Neuro Ventricular Cannula, 16 ga, .008” ID x 4 ft x 15mm tip