Dib UltraNav Transseptal Catheter System

GUDID 00860013955946

Dib UltraNav Medical LLC

Cardiac transseptal access set

• Primary Device ID: 00860013955946
• NIH Device Record Key: e287cd0a-5676-4ecb-b488-2ae7de4426c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dib UltraNav Transseptal Catheter System
• Version Model Number: DIB-025
• Company DUNS: 119495607
• Company Name: Dib UltraNav Medical LLC
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013955946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213492

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-16
• Device Publish Date: 2025-05-08

On-Brand Devices [Dib UltraNav Transseptal Catheter System]

• 00860013955977: DIB-040
• 00860013955960: DIB-035
• 00860013955953: DIB-030
• 00860013955946: DIB-025