Neonav® ECG Tip Location System NV1-SYS-ALL

GUDID 09369998531356

NAVI MEDICAL TECHNOLOGIES PTY LTD

Central venous catheter navigation system, electrocardiographic

• Primary Device ID: 09369998531356
• NIH Device Record Key: 178938a3-2972-4927-82fa-68f81a3f6731
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neonav® ECG Tip Location System
• Version Model Number: NV1-SYS-ALL
• Catalog Number: NV1-SYS-ALL
• Company DUNS: 744820670
• Company Name: NAVI MEDICAL TECHNOLOGIES PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	09369998531356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241910

FDA Product Code

• LJS: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-03
• Device Publish Date: 2025-08-26

Devices Manufactured by NAVI MEDICAL TECHNOLOGIES PTY LTD

• 19369900073438 - Neonav® Clip Cable: 2025-09-03
• 09369998531356 - Neonav® ECG Tip Location System: 2025-09-03
• 09369998531356 - Neonav® ECG Tip Location System: 2025-09-03
• 09369999358679 - Neonav® ECG Adapter: 2025-09-03
• 19369999359611 - Neonav® Adapter Cable: 2025-09-03