Neonav® Adapter Cable NV1-CN-ADC

GUDID 19369999359611

NAVI MEDICAL TECHNOLOGIES PTY LTD

Central venous catheter navigation system, electrocardiographic

• Primary Device ID: 19369999359611
• NIH Device Record Key: c4576d83-546f-4c4f-bb0d-fc7ec8b32fef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neonav® Adapter Cable
• Version Model Number: NV1-CN-ADC
• Catalog Number: NV1-CN-ADC
• 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: 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	09369999359614 [Primary]
GS1	19369999359611 [Package]; Contains: 09369999359614; Package: Box [20 Units]; In Commercial Distribution

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: true

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
• 09369999358679 - Neonav® ECG Adapter: 2025-09-03
• 19369999359611 - Neonav® Adapter Cable: 2025-09-03
• 19369999359611 - Neonav® Adapter Cable: 2025-09-03